Identity
- Trade Name
- EpiDisc TM Perf Patch Kit FDA UDI
- Generic Name
- Tympanic membrane prosthesis FDA UDI
- Device Name
- EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. FDA UDI
- Model / Reference
- 653-160 FDA UDI
- Description
- EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. FDA UDI
Identifiers
- Catalog Number
- 1417151 FDA UDI
- Primary DI / UDI-DI
- 08033549790998 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
Yes
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
EpiDisc TM Perf Patch Kit 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anika Therapeutics, Inc.
Sources (1)
- FDA UDI 5f790052-f591-40ff-a83c-cfdd33b1a104 35 fields · synced Jun 9, 2026