MEROGEL 1PK 4x4cm 1517000

GUDID 08033549791124

Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery, and in otologic packing, to act as an adjunct to aid in the natural healing process.

Anika Therapeutics, Inc.

Intranasal splint, biodegradable

• Primary Device ID: 08033549791124
• NIH Device Record Key: 24b3f3b2-77eb-4f04-84bd-7011cf58019e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEROGEL 1PK 4x4cm
• Version Model Number: 651140
• Catalog Number: 1517000
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033549791124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982731

FDA Product Code

• EMX: Balloon, Epistaxis

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: 2024-04-26
• Device Publish Date: 2024-04-18

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: 2025-06-12 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