Monovisc

GUDID 00817337000104

Crosslinked Sodium Hyaluronate 22 mg/mL

Anika Therapeutics, Inc.

Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium 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.

• 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
• M06760001220 - Integrity Cannula/Obturator Kit: 2023-11-17 Integrity Cannula and Obturator, single-use
• 08033549791063 - Epifilm Otologic: 2022-02-14 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
• 00817337000128 - Ophthalin: 2022-01-06 0.8 ml, 1.2% OVD Sodium Hyaluronate