FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Epifilm Otologic
DI: 08033549790738
·
Model: 653-200
·
Anika Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epifilm Otologic
- Primary DI
- 08033549790738
- Version / Model
- 653-200
- Catalog Number
- 1417000
- Company Name
- Anika Therapeutics, Inc.
- Labeler DUNS
- 807613393
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-19
- Public Version
- 4
- Public Version Date
- 2025-06-12
- Public Version Status
- Update
- Public Device Record Key
- 4c7e8aed-7677-4f6f-a374-7c276cf39a40
- Distribution End Date
- 2025-06-11
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34410 | Tympanic membrane prosthesis | A device intended for the repair or replacement of the membrana tympani of the middle ear typically implanted during ear/nose/throat (ENT) surgery. It is made of synthetic polymer material. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033549790738 | GS1 |