BIOMESH®CA.B.S.'Air®

GUDID 03760185570381

The BIOMESH® CA.B.S.'Air® prosthesis consists of (according to the references on the box): - A parietal prosthesis made of a plug and a polypropylene mesh and two polyethylene terephthalate and ePTFE fixation threads crimped of stainless steel needles. - A balloon which allows the deployment of the parietal prosthesis

COUSIN BIOTECH

Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer

• Primary Device ID: 03760185570381
• NIH Device Record Key: 02aa8746-6560-475f-874c-9eefcd916701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMESH®CA.B.S.'Air®
• Version Model Number: CABS06P1
• Company DUNS: 776742439
• Company Name: COUSIN BIOTECH
• 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

Customer Support Contacts

• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com
• Phone: +33320144000
• Email: contact@cousin-biotech.com

Device Dimensions

• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
• Special Storage Condition, Specify: Between 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760185570381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072962

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

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: 2020-10-21
• Device Publish Date: 2015-10-23