4DDOME®

GUDID 03760185572927

The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.

COUSIN BIOTECH

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 03760185572927
• NIH Device Record Key: 29648d74-015c-4ad7-a63f-954fa35c411a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4DDOME®
• Version Model Number: 4DDOM24GSR
• 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: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 24 Millimeter
• Height: 15 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760185572927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070918

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

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• 03760185572323 - 4DDOME ®: 2020-10-21 The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
• 03760185572347 - 4DDOME ®: 2020-10-21 The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.