Batch Codes, Expiry Dates and Storage for Aesthetic Device Consumables

A federal regulation sets how a date on a device label is written, if the label carries one. The part's GUDID record gives a Yes or a No for lot or batch number, serial number, expiration date and manufacturing date. Where a SkinPen Precision cartridge's shelf life is counted from, and which piece of equipment a storage range belongs to for SkinPen Precision and Ultherapy, is written in the manufacturer's instructions. An order request that quotes only one of these documents leaves the other two unanswered. The page covers consumables with a GUDID record read for this page, for the US market only.

What federal rules say about a date on the label

Under 21 CFR 801.18, a date printed on a device label is written as year, month and day, four digits for the year and two each for the month and day, separated by hyphens, and the rule sets that format for a date the label includes. The section opens with the words "Whenever the label of a medical device includes a printed expiration date", in the eCFR text of part 801, subpart A (up to date as of September 15, 2026, read on September 24, 2026). The same format covers the manufacturing date and any other date meant for the user, with exceptions in 801.18(b) for a combination product that carries an NDC number and for the manufacturing date of electronic products under a standard in subchapter J. When a seller quotes a date in a shorter form, such as a month and a year, ask for the full date exactly as it stands on the label.

The label itself is governed by part 801, subpart B (up to date as of September 21, 2026, read on September 24, 2026). Section 801.20(a) states that "The label of every medical device shall bear a unique device identifier (UDI)", and 801.40(a) sets two forms for it, easily readable plain text and automatic identification and data capture (AIDC) technology such as a bar code. The definitions in 801.3 and in part 830, subpart A (830.3 up to date as of September 22, 2026, read on September 24, 2026) split the UDI into a mandatory, fixed device identifier for the model and a conditional, variable production identifier. Under 801.40(b), the production identifier is required whenever the label includes a lot or batch number, a serial number, a manufacturing date or an expiration date. For an order, the device identifier confirms the model, and the lot, serial number or date you have to ask about belongs to the variable part.

Section 801.30(a)(3) lets individual single-use devices of one model, distributed together and stored in one package, go without a UDI on each unit, and adds that "The device package containing these individual devices is not excepted." In that case the package has to bear the UDI, with any date in its production identifier, while each piece may go without one. Ask the seller whether the date you will receive is printed on the outer package or on each unit, and if a box is split before it ships, ask which package the units travel in.

Which production identifiers eight GUDID records declare

Six of the eight consumable records selected for this page and read in GUDID on September 24, 2026 answer Yes for Expiration Date, and the two that answer No, the Morpheus8 24-pin tip and the Thermage CPT tip, answer Yes for Lot or Batch Number and Manufacturing Date. Each record gives a Yes or a No against four production identifiers, and the table copies those answers as the records state them. The Ultherapy DS 4-4.5 transducer and the Potenza tip Combo-box are the two records with Yes for Serial Number and No for Lot or Batch Number, while both SkinPen cartridges have Yes for lot and expiration date and No for manufacturing date. In the request, ask the seller for the identifiers these records answer Yes for: Lot or Batch Number for a SkinPen cartridge, Serial Number for an Ultherapy transducer or a Potenza tip.

In these eight records selected for this page and read on September 24, 2026, Lot or Batch Number: Yes appears six times, Serial Number: Yes twice and Manufacturing Date: Yes six times; the counts describe this selection, not the GUDID database as a whole. Only the Morpheus8 record gives a storage range for the part. The other seven show the entry "No storage/handling found" under Storage and Handling, and the table records it as none found. For those seven parts, ask the manufacturer or the seller which storage range applies to the part itself. For catalog numbers, see the catalog number cross-reference.

Where the shelf life is written and what it counts from

The SkinPen Precision instructions put cartridge shelf life at two years from the sterilization date, while the Ultherapy PRIME instructions tell you to check the expiration date on the transducer package.

The SkinPen Precision instructions, read on September 24, 2026, state "The shelf life of this needle cartridge is 2 years from sterilization date." and describe the cartridge as sterilized with ethylene oxide and packaged and labeled individually. Because the count starts at sterilization, it does not run from the day you buy the cartridge. Ask the seller which expiration date stands on the label of the cartridges you will receive rather than counting two years forward yourself; the REF014 record answers Yes in the field Expiration Date. Two FDA decision summaries give the same period, with 510(k) summary K192138 stating "The shelf life of the handheld unit and microneedle cartridge is 2 years" and 510(k) summary K203144 listing "Shelf Life (Cartridge) 2 years" (both read on September 23, 2026). See also cartridges for SkinPen Precision.

The Ultherapy PRIME instructions dated April 2026, read on September 24, 2026, state in section 3.2.3 that "A label atop the transducer provides the transducer type, expiration date, and other information." and in section 5.4.2 give the instruction "Check the expiration date on the transducer package." The earlier instructions 1015107IFU Rev A, revision date October 2021, read on September 24, 2026, state in section 9.2 "Always check the expiration date on the transducer before using. Expired transducers should not be used." The date that governs a transducer is therefore the one printed on its own label and package, and your request should ask for it transducer by transducer. See also Ultherapy transducers.

The FDA decision K231287 for Jeisys Medical Inc. (read on September 20, 2026) quotes the device labeling for three tips added for the S handpiece as "1 use or 2 years, whichever occurs first"; see also RF microneedling devices compared.

The GUDID records for the Morpheus8 24-pin tip and the Thermage CPT 3.00 cm² tip (both read on September 24, 2026) answer Yes for Manufacturing Date and No for Expiration Date. A manufacturing date on its own is not an expiration date, and this page does not derive one from it. Before ordering either tip, ask the manufacturer or the seller whether a use-by period is stated in writing for that tip, and ask for the document that states it.

Storage range for the part versus the system

Only one of the eight consumable records selected for this page, the Morpheus8 24-pin tip, gives a storage range for the part itself, 10 to 35 °C, while the SkinPen Precision instructions give their range for the device and the Ultherapy PRIME instructions give one range for transducers and another for the console.

The Ultherapy PRIME instructions dated April 2026 (read on September 24, 2026) give "Shipping and Storage, Transducers: 15 to 30°C (59 to 86°F) Room Temperature, 15 to 95% R.H." for transducers and minus 20 to 65 °C for the system without transducers. The same document lists an operating environment of 10 to 30 °C and 30 to 85% RH for the system, handpiece and transducers in use, which is a condition for treatment and not a storage range. The October 2021 Rev A instructions (read on September 24, 2026) give the same transducer range in section 3.3.12 and add protection from freezing. A storeroom that stays inside the console range can still fall outside the transducer range, so compare your storage with 15 to 30 °C when transducers are on the shelf.

In the SkinPen Precision instructions (read on September 24, 2026), the range of 17 to 30 °C and 30 to 75% RH sits in section 14, "Environmental Conditions", as "Storage and Operating conditions" for the device, meaning the handpiece and charging base. That range belongs to the pen, and the cartridge record shows the entry "No storage/handling found". Ask the manufacturer which storage range applies to the cartridges before you set the storeroom to the device figure.

The Morpheus8 24-pin tip record (read on September 24, 2026) gives storage at 10 to 35 °C, 0 to 90% RH and 50 to 106 kPa, and handling at 10 to 35 °C and 10 to 90% RH. Compare your storeroom with that range before tips go on the shelf.

What the Merz and InMode terms say about returning consumables

The Merz Aesthetics terms dated September 15, 2026 say expired product is in no event returnable or replaced by Merz. The Merz terms and conditions, read on September 23, 2026, state in section 4 on page 2 "In no event will promotional Product or expired Product be returnable or replaced by Merz." Under a heading for Ultherapy DeepSEE and Ultherapy PRIME products, the same document adds "Delivered Products which have been purchased may not be returned." Under these terms, the order quantity has to fit the time left on the label. See also who can buy professional consumables in the US.

The InMode US terms, read on September 23, 2026, deal with consumables at the point of a system upgrade and say that supplies for the original System that the customer holds at that time "will not be replaced by Company or returnable for any refund or other credit". The clause concerns upgrades rather than dates, so plan an upgrade with the stock of the old system run down first.

What to ask the seller before the order ships

Under 21 CFR 801.18, a date printed on a device label is written as year, month and day, so ask the seller for the expiration date of the lot before the order ships.

1. The expiration date of the lot, or of each serial number for Ultherapy transducers and Potenza tips, written as year, month and day as it stands on the label.
2. For Morpheus8 24-pin and Thermage CPT tips, whether the manufacturer states a use-by period in writing, since the record answers No for Expiration Date and a manufacturing date is not a substitute.
3. For SkinPen Precision and Precision Elite cartridges, whether each lot's label carries an expiration date and which one, since the SkinPen Precision instructions count shelf life from sterilization.
4. The seller's shipping and storage temperatures for Ultherapy transducers compared with the transducer range of 15 to 30 °C, and its storage temperatures for the Morpheus8 24-pin tip compared with the storage range of 10 to 35 °C in the tip's record.
5. Whether the date and the UDI are printed on the outer package or on each unit.
6. A quantity that you will use before the label date, since the Merz terms exclude return or replacement of expired Merz product.

Put these six points into one written inquiry, with the part names and quantities you need, and send it through Request a quote. For the check when the parcel arrives, see how to check an aesthetic device consumable on delivery.

FAQ

Where does the expiration date for the box I receive come from?

In the eight records read for this page, the field Expiration Date holds Yes or No. The definition in 21 CFR 801.3 (eCFR text current to September 15, 2026) reads "The date by which the label of a device states the device must or should be used.", which points back to the label, so request the date as printed on your lot's label.

Which of lot or serial number does the Ultherapy transducer record mark Yes?

The GUDID record for the DS 4-4.5 transducer lists Serial Number: Yes and Lot or Batch Number: No, and the April 2026 PRIME instructions say the label on top of each transducer carries a unique serial number and the date of manufacture. The same passage in section 5.4.2 lists a part number and the transducer name with frequency and depth, written as DS X-X, so quote the serial number and the part number when you ask about one specific transducer.