Identity
- Trade Name
- Epifilm Otologic FDA UDI
- Generic Name
- Tympanic membrane prosthesis FDA UDI
- Device Name
- Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. FDA UDI
- Model / Reference
- 653-200 FDA UDI
- Description
- Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. FDA UDI
Identifiers
- Catalog Number
- 1417000 FDA UDI
- Primary DI / UDI-DI
- 08033549791063 FDA UDI
- FDA Product Code
- KHJ FDA UDI
- GMDN Term
- Tympanic membrane prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Epifilm Otologic by Anika Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Anika Therapeutics, Inc.
Sources (1)
- FDA UDI 92778f9a-6f66-46e6-be4c-742351502168 36 fields · synced Jun 9, 2026