Ophthalin

GUDID 00817337000128

0.8 ml, 1.2% OVD Sodium Hyaluronate

Anika Therapeutics, Inc.

Vitreous/aqueous humour replacement medium, intraoperative

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817337000128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000046

FDA Product Code

• LZP: Aid, Surgical, Viscoelastic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-06
• Device Publish Date: 2021-12-29

Devices Manufactured by Anika Therapeutics, Inc.

• 00817337000425 - Integrity Implant: 2025-09-29 Integrity Implant, 40mm x 60mm
• 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.