Primary Device ID | 00817337000128 |
NIH Device Record Key | 8d572fbe-25e0-4ba7-88d9-0a3e1938060d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ophthalin |
Version Model Number | 6000080 |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817337000128 [Primary] |
LZP | Aid, Surgical, Viscoelastic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-01-06 |
Device Publish Date | 2021-12-29 |
08033549790738 - Epifilm Otologic | 2025-06-12 Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the na |
08033549790745 - Epidisc 2pk Otologic 8mm | 2025-06-12 EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healin |
08033549790752 - EpiDisc TM Perf Patch Kit | 2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. |
08033549790769 - Merogel Injectable | 2025-06-12 MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to c |
08033549790974 - Epifilm Otologic | 2025-06-12 Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the na |
08033549790981 - Epidisc 2pk Otologic 8mm | 2025-06-12 EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healin |
08033549790998 - EpiDisc TM Perf Patch Kit | 2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. |
00817337000319 - Deployment Skid Cannula Access Tool | 2024-05-23 Reusable non-rigid cannula access tool |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() OPHTHALIN 90385819 not registered Live/Pending |
Carl Zeiss Meditec AG 2020-12-16 |
![]() OPHTHALIN 74591666 2410904 Dead/Cancelled |
HYALTECH LTD. 1994-10-28 |