Identity
- Trade Name
- Trinity Sterile, Inc. FDA UDI
- Generic Name
- Oral care kit, single-use FDA UDI
- Device Name
- DENTURE CARE KIT FDA UDI
- Model / Reference
- 85287UMROI FDA UDI
- Description
- DENTURE CARE KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841767107451 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Oral care kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Oral care kit, single-use
Trinity Sterile, Inc. by Trinity Sterile, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
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- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Trinity Sterile, Inc.
Sources (1)
- FDA UDI c273ffcf-1381-49d3-9f2d-7f94206a6b21 33 fields · synced May 31, 2026