Monovisc

GUDID 00817337000104

Crosslinked Sodium Hyaluronate 22 mg/mL

Anika Therapeutics, Inc.

Synovial fluid supplementation medium

• Primary Device ID: 00817337000104
• NIH Device Record Key: ae0edbd2-9ceb-4f2f-80f4-5ca5264f5d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monovisc
• Version Model Number: 690016
• 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	00817337000104 [Primary]

FDA Product Code

• MOZ: Acid, Hyaluronic, Intraarticular

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: 2021-12-15
• Device Publish Date: 2021-12-07

Devices Manufactured by Anika Therapeutics, Inc.

• 00817337000319 - Deployment Skid Cannula Access Tool: 2024-05-23 Reusable non-rigid cannula access tool
• 08033549791117 - MEROGEL 2pk 4x4cm: 2024-04-26 Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separat
• 08033549791124 - MEROGEL 1PK 4x4cm: 2024-04-26 Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separat
• M06760001020 - Integrity Implant Fixation Kit: 2023-11-22 Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy.
• M06760001180 - Integrity Delivery Instrument, Bone Staple: 2023-11-22 Integrity bone staple delivery instrument, single-use
• M06760001200 - Integrity Delivery Instrument, Tissue Tack: 2023-11-22 Integrity tissue tack delivery instrument, single use
• 00817337000241 - Integrity Implant: 2023-11-17 Integrity Implant, 20mm x 25mm
• 00817337000258 - Integrity Implant: 2023-11-17 Integrity Implant, 25mmx30mm