Who else makes this device?

Name: Sterim
Brand: Sterim

General Hospital › MonitoringIndicator, Biological Sterilization Process

Sterim

2 catalogue numbers from SRI-050, listed by True Indicating LLC, United States, under Indicator, Biological Sterilization Process. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FRC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15

Record

Regulatory record for Sterim
Listed by	True Indicating LLC, United States
FDA product code	FRC
Device type	Indicator, Biological Sterilization Process
Device class	Class 2
Regulation	21 CFR 880.2800
Establishment	Repacker / relabeller, Manufacturer
510(k)	K200970
Record published	2023-04-28

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment humidity 20 to 80 % RH; Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for Sterim
Catalogue number	Size	Status
SRI-050		In distribution
SBI-100		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bionova®	Terragene S.A.	47
Attest™	3M Company	36
Verify	Steris Corporation	27
3M™ Attest™	3M Company	16
Celerity	Steris Corporation	15
Biotrace™	Terragene S.A.	11
Single Species BI Strip	Crosstex International	11
Tuttnauer®	Terragene S.A.	10
Sterrad Velocity™	Advanced Sterilization Products Services Inc.	8
GPS	Group Practice Solutions	7
Henry Schein	Henry Schein, Inc.	7
Propper Duo Spore Biological Indicators	Propper Manufacturing Co., Inc.	7

Showing 12 of 173. All products under Indicator, Biological Sterilization Process

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200970	2020-12-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.