Anikavisc

GUDID 00866142000045

0.8 ml, 12 mg/mL Sodium Hyaluronate

Anika Therapeutics, Inc.

Vitreous/aqueous humour replacement medium, intraoperative

• Primary Device ID: 00866142000045
• NIH Device Record Key: 8b0d474b-4781-456c-a9ed-646285699b1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anikavisc
• Version Model Number: 600-106
• 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	00866142000045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000046

FDA Product Code

• LZP: Aid, Surgical, Viscoelastic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-30

On-Brand Devices [Anikavisc]

• 00866142000045: 0.8 ml, 12 mg/mL Sodium Hyaluronate
• 00866142000052: 0.8 ml, 1.2% OVD Sodium Hyaluronate