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Device Explorer · FDA GUDID · GMDN 13735

Sterilization packaging, single-use

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 devices3,078in commercial distribution
Companies96labelers on GUDID
Single‑use100%of device records
Sterile3%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Medline Industries, Inc.43314%
Cardinal Health 200, Llc1816%
Sterimed Inc.1695%
O&M Halyard, Inc.1395%
Amd Medicom Inc1284%
Wipak Oy1214%
Primed Medical Products Inc1053%
Vivit Supply Llc1053%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.43314%
Cardinal Health 200, Llc1816%
Sterimed Inc.1695%
O&M Halyard, Inc.1395%
Amd Medicom Inc1284%
Wipak Oy1214%
Primed Medical Products Inc1053%
Vivit Supply Llc1053%
Henry Schein, Inc.783%
Crosstex International, Inc.742%
Care Essentials Pty Ltd722%
Owens & Minor Distribution, Inc.702%

Company = labeler of record on GUDID. 96 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Carerite®CARATESterilization Pouches and ReelsEMSRUNFOMEDGUANGZHOU MAIDI MEDICALCOTISENSteriking®STERIKING®AN2300.50 Tyvek Pouch, 50 countDarby Dental Supply, LLCBritedentDental MatesDDS Dental SuppliesPatient Armor Sterilization PouchesJMU

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

FDA product codes

CodeNameDevices
FRGWrap, sterilization1,660
FRGWrap, Sterilization1,225
KCTSterilization Wrap Containers, Trays, Cassettes & Other Acce392
KCTSterilization wrap containers, trays, cassettes & other acce278
JOJIndicator, Physical/Chemical Sterilization Process167
JOJIndicator, physical/chemical sterilization process66

GMDN & GCC registration

  • GMDN code 13735 · non‑implantable
  • Single‑use 100% · sterile 3% · Rx‑only 5% · OTC 33%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 203Length (Inch) · 168Area/Surface Area (Square inch) · 14Length (Feet) · 10Weight (Pound) · 8Height (Inch) · 8

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

How many sterilization packaging, single-use products are registered in the US?

3,078 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sterilization packaging, single-use", from 96 companies. The largest labeler is Medline Industries, Inc. with 14% of records.

Which FDA product codes apply?

FRG (Wrap, sterilization), FRG (Wrap, Sterilization), KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Acce), 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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