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Device Explorer · FDA GUDID · GMDN 40517

Sterilization packaging, reusable

A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of

US‑registered devices753in commercial distribution
Companies14labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription18%Rx‑only share
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Share of device records

Zirc Dental Products, Inc.25534%
Medline Industries, Inc.17523%
Peter Brasseler Holdings, Llc13318%
Standard Textile Co., Inc.8011%
Encompass Group, L.L.C.334%
Lac-Mac Limited284%
Innovative Sterilization Techn172%
Orthopli Corp.101%

Top labelers

CompanyDevicesShare
Zirc Dental Products, Inc.25534%
Medline Industries, Inc.17523%
Peter Brasseler Holdings, Llc13318%
Standard Textile Co., Inc.8011%
Encompass Group, L.L.C.334%
Lac-Mac Limited284%
Innovative Sterilization Techn172%
Orthopli Corp.101%
Benco Dental Supply Co.91%
Elevate Textiles, Inc.41%
Patterson Dental Supply, Inc.30%
Sri Healthcare, Llc30%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Brasseler USAONE TRAY® Sealed Sterilization ContainerNOVADAQ®and PINPOINT®OrthopliSRI HealthcareSteri-Endo Guard - Endo Holder - Hand - Neon PinSteri-Endo Guard - Endo Holder - Hand - Neon PurSteri-Endo Guard - Endo Holder - Hand - Neon OraSteri-Endo Guard - Endo Holder - Hand - Neon GreSteri-Endo Guard - Endo Holder - Hand - Neon YelSteri-Endo Guard - Endo Holder - Hand - Neon BluSteri-Endo Guard - Endo Holder - Hand - Copper -Steri-Endo Guard - Endo Holder - Hand - MidnightSteri-Endo Guard - Endo Holder - Hand - Red - 1 Steri-Endo Guard - Endo Holder - Hand - Teal - 1Steri-Endo Guard - Endo Holder - Hand - Plum - 1

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FRGWrap, sterilization341
FSMTray, Surgical, Instrument264
FRGWrap, Sterilization179
KCTSterilization Wrap Containers, Trays, Cassettes & Other Acce30
KCTSterilization wrap containers, trays, cassettes & other acce1

GMDN & GCC registration

  • GMDN code 40517 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 18% · OTC 34%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 28Width (Inch) · 23

Use these as the dimensions to specify in a tender line.

How many sterilization packaging, reusable products are registered in the US?

753 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sterilization packaging, reusable", from 14 companies. The largest labeler is Zirc Dental Products, Inc. with 34% of records.

Which FDA product codes apply?

FRG (Wrap, sterilization), FSM (Tray, Surgical, Instrument), FRG (Wrap, Sterilization), KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Acce)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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