Freedom - Ventral Hernia Repair System FVHR28X35

GUDID 00837654352991

The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.

INSIGHTRA MEDICAL, INC.

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 00837654352991
• NIH Device Record Key: 8409eaff-3be1-4f17-8024-1f3fbeef19c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom - Ventral Hernia Repair System
• Version Model Number: FVHR28X35
• Catalog Number: FVHR28X35
• Company DUNS: 097664937
• Company Name: INSIGHTRA MEDICAL, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00837654352991 [Package]; Contains: 00850012832317; Package: [5 Units]; In Commercial Distribution
GS1	00850012832317 [Primary]
GS1	00850012832324 [Package]; Contains: 00850012832317; Package: Shipper Box Implant [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142192

FDA Product Code

• OXJ: Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-07-22

On-Brand Devices [Freedom - Ventral Hernia Repair System]

• 00850012832348: The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
• 00837654352991: The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
• 00837654352984: The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
• 00850012832256: The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
• 00837654352960: The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene