Orthovisc

GUDID 00817337000111

Mitek Orthovisc, 2 mL, US

Anika Therapeutics, Inc.

Synovial fluid supplementation medium

• Primary Device ID: 00817337000111
• NIH Device Record Key: 6c4c2984-2a1d-4daf-bef3-c54ea0e5dd12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthovisc
• Version Model Number: 630254
• 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

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
• 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	00817337000111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030019

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