| Primary Device ID | 08033549790974 |
| NIH Device Record Key | e3200a17-1c66-4b4c-9cc4-9468b942abef |
| Commercial Distribution Discontinuation | 2025-06-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Epifilm Otologic |
| Version Model Number | 653-200 |
| Catalog Number | 1417000 |
| Company DUNS | 807613393 |
| Company Name | Anika Therapeutics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033549790974 [Primary] |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-06-12 |
| Device Publish Date | 2018-11-08 |
| 08033549791018 | Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs an |
| 08033549791063 | Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs an |
| 08033549790974 | Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs an |
| 08033549790738 | Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs an |