Integrity Implant

GUDID 00817337000425

Integrity Implant, 40mm x 60mm

Anika Therapeutics, Inc.

Extra-gynaecological surgical mesh, composite-polymer

• Primary Device ID: 00817337000425
• NIH Device Record Key: de12cc06-4482-4932-996e-1e8f3805f7ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity Implant
• Version Model Number: 6000114
• 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	00817337000425 [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: 2025-09-29
• Device Publish Date: 2025-09-19

On-Brand Devices [Integrity Implant]

• 00817337000258: Integrity Implant, 25mmx30mm
• 00817337000241: Integrity Implant, 20mm x 25mm
• 00817337000425: Integrity Implant, 40mm x 60mm