Identity
- Trade Name
- TearRepair FDA UDI
- Generic Name
- Synthetic-polymer liquid barrier dressing FDA UDI
- Model / Reference
- TR100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013046415 FDA UDI
- 510(k) Number
- K241916 FDA UDI
- FDA Product Code
- KMF FDA UDI
- GMDN Term
- Synthetic-polymer liquid barrier dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5090 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic-polymer liquid barrier dressing
TearRepair by Optmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Optmed, Inc.
Sources (1)
- FDA UDI f4c27f71-290d-4b5d-b22b-ef20ae7e1b03 33 fields · synced May 31, 2026