FDA device listing
01 0001 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap,01 0038 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm…
FDA device listing 1890784403 · Sotera Health LLC
Key facts
| Proprietary names | 01 0001 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap,01 0038 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap,02 0002 Cardinal Health™ Specimen Container, 90mL/48mm, ORG Cap,02 0002 Cardinal HealthTM Specimen Container, 90mL/48mm, ORG Cap,02 0016 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap,02 0038 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FMH |
| Device names | FMH - Container, Specimen, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | COMPANHIA BRASILEIRA DE ESTERILIZACAO, Sterigenics Italy SpA, Sterigenics S. de R.L. de C.V., Sterigenics Shanghai E Beam Ltd., Sterigenics Shanghai ETO Ltd., Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1036836, 1058584, 1061124, 1319639, 1423662, 1526534, 1649518, 2011171, 2022435, 2029015, 2029275, 2245590, 9616517, 3002907620, 3004111573, 3007007790, 3008132411, 3008328679, 3010370650, 3010407203 |
| FEI numbers | 1036836, 1526534, 2011171, 2022435, 2245590, 1000138054, 1000160458, 1000219637, 1000306431, 1000512168, 3000215273, 3001236277, 3002907620, 3003117688, 3004111573, 3007007790, 3008132411, 3008328679, 3010165944, 3010407203 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database