Integrity Implant

GUDID 00817337000241

Integrity Implant, 20mm x 25mm

Anika Therapeutics, Inc.

Extra-gynaecological surgical mesh, composite-polymer

• Primary Device ID: 00817337000241
• NIH Device Record Key: 8a380a35-ee70-4332-a16f-5c3a1b24431a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity Implant
• Version Model Number: 6000100
• Company DUNS: 807613393
• Company Name: Anika Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00817337000241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223538

FDA Product Code

• OWX: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

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: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [Integrity Implant]

• 00817337000258: Integrity Implant, 25mmx30mm
• 00817337000241: Integrity Implant, 20mm x 25mm