Biomesh® CA.B.S.’Air® Composite

GUDID 03760185570343

The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug, two polyethylene terephthalate with biocompatible colorant (D&C Green #6) and ePTFE fixation threads crimped of stainless steel needles. - A balloon which allows the deployment of the parietal prosthesis.

COUSIN BIOTECH

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• Primary Device ID: 03760185570343
• NIH Device Record Key: 638fe56b-a25c-4e7e-81f0-53a955938d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomesh® CA.B.S.’Air® Composite
• Version Model Number: CABSAIRC7
• 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: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 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	03760185570343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093196

FDA Product Code

• OQL: Mesh, Surgical, Deployment Balloon

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

On-Brand Devices [Biomesh® CA.B.S.’Air® Composite]

• 03760185570374: The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of a
• 03760185570343: The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of a
• 03760185570336: The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of a