Merogel Injectable CFN 1518000

GUDID 08033549790769

MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to create a physical separation of mucosal surfaces with the purpose of preventing adhesions during the post-operative healing process

Anika Therapeutics, Inc.

Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

• Primary Device ID: 08033549790769
• NIH Device Record Key: 211290da-2043-41f7-a5ab-13941590b28a
• Commercial Distribution Discontinuation: 2025-06-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Merogel Injectable
• Version Model Number: 640-023
• Catalog Number: CFN 1518000
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033549790769 [Primary]

FDA Product Code

• NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2025-06-12
• Device Publish Date: 2016-09-24

Devices Manufactured by Anika Therapeutics, Inc.

• 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: 2025-06-12MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to create a physical separation of mucosal surfaces with the purpose of preventing adhesions during the post-operative healing process
• 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