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Device Explorer · FDA GUDID · GMDN 35362

Chemical/physical sterilization process indicator

A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization proc

US‑registered devices521in commercial distribution
Companies47labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription6%Rx‑only share
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Share of device records

Propper Manufacturing Company, Inc.6613%
Weihai Xingtai Packaging Products Co.,Ltd.499%
Terragene S.A.469%
Sps Medical Supply Corp.387%
Steritec Product Mfg. Co., Inc.347%
3M Company347%
Hu-Friedy Mfg. Co., Llc265%
Nevs Ink, Inc.245%

Top labelers

CompanyDevicesShare
Propper Manufacturing Company, Inc.6613%
Weihai Xingtai Packaging Products Co.,Ltd.499%
Terragene S.A.469%
Sps Medical Supply Corp.387%
Steritec Product Mfg. Co., Inc.347%
3M Company347%
Hu-Friedy Mfg. Co., Llc265%
Nevs Ink, Inc.245%
Albert Browne Limited224%
Steris Corporation204%
Medline Industries, Inc.153%
Aesculap, Inc.132%

Company = labeler of record on GUDID. 47 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SimeloRMH3 DENTALBaylabAN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour ExpoAN87 Dosimeter, Chemical IndicatorAN1087 Dosimeter, Chemical IndicatorAN86 EO Indicator, Type 1 Process IndicatorAN85 EO Indicator, Type 1 Process IndicatorAESCULAPAICONDarby Dental Supply, LLCNev's Ink Inc.Nev's Ink, Inc.Instant 20s IndicatorJMUAUTOCLAVE TAPE

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

FDA product codes

CodeNameDevices
JOJIndicator, physical/chemical sterilization process272
JOJIndicator, Physical/Chemical Sterilization Process248
FRGWrap, Sterilization51
KCTSterilization wrap containers, trays, cassettes & other acce17
FRGWrap, sterilization14
LRTIndicator, Sterilization11

GMDN & GCC registration

  • GMDN code 35362 · non‑implantable
  • Single‑use 98% · sterile 0% · Rx‑only 6% · OTC 43%
  • 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) · 21Length (Yard) · 19Length (Inch) · 9Area/Surface Area (Square inch) · 2Length (Feet) · 1

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

No closely related category with 50+ devices.

How many chemical/physical sterilization process indicator products are registered in the US?

521 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Chemical/physical sterilization process indicator", from 47 companies. The largest labeler is Propper Manufacturing Company, Inc. with 13% of records.

Which FDA product codes apply?

JOJ (Indicator, physical/chemical sterilization process), JOJ (Indicator, Physical/Chemical Sterilization Process), 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.

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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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