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Sign in to claim this brandTRINITY STERILE, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 201 Kiley Dr, SALISBURY, MD, 21801
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000123297
- DUNS Number
- —
Catalogue (390)
Page 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trinity Sterile, Inc. | 50198 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 85287UCMC | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 20205 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 11207 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 81430 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 6090 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 6021 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 50287 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 85286SH | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 50265 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 85286UCMC | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | T97-793 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 6047 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | T98-503 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 10086 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | T97-791 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 85384 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 85381 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 5055 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 6007 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 50616 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | T98-224 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 22002 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 6018 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 81374 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 2268 | FDA UDI | N | Active |
| Trinity Sterile, Inc. | 5099 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | T97-710 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 7024 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 10103 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 50908 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | T98-374 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 1200LG | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 85365 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 5063 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 5080 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 50188 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 85286UMT | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 96-3566A | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 6096 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 50613 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 85286UMROI | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 5041 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 50513A | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | 20321 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 50267 | FDA UDI | Class II | Active |
| Trinity Sterile, Inc. | T98-234 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 81663 | FDA UDI | Class I | Active |
| Trinity Sterile, Inc. | 5064 | FDA UDI | N/A | Active |
| Trinity Sterile, Inc. | 7225 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 13, 2024 | Z-1012-2025 | — | open, classified | Potential for hole in package compromising sterility of the medical kit. |
| Dec 13, 2024 | Z-1016-2025 | — | open, classified | Potential for hole in package compromising sterility of the medical kit. |
| Dec 13, 2024 | Z-1015-2025 | — | open, classified | Potential for hole in package compromising sterility of the medical kit. |
| Dec 13, 2024 | Z-1013-2025 | — | open, classified | Potential for hole in package compromising sterility of the medical kit. |
| Dec 13, 2024 | Z-1014-2025 | — | open, classified | Potential for hole in package compromising sterility of the medical kit. |
| Jun 29, 2022 | Z-1551-2022 | — | terminated | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy |
| Jun 29, 2022 | Z-1548-2022 | — | terminated | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy |
| Jun 29, 2022 | Z-1550-2022 | — | terminated | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy |
| Jun 29, 2022 | Z-1549-2022 | — | terminated | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy |
| Feb 23, 2021 | Z-1468-2021 | — | terminated | Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility |