ProGrip

GUDID 10884521844285

Self-Gripping Polypropylene Mesh Polypropylene with Polylactic Acid Grips

SOFRADIM PRODUCTION

Extra-gynaecological surgical mesh, composite-polymer

• Primary Device ID: 10884521844285
• NIH Device Record Key: 4ce43447-1010-4d9e-a33b-44d439330ce3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGrip
• Version Model Number: PP2015G
• Company DUNS: 576342646
• Company Name: SOFRADIM PRODUCTION
• 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: 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521844285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232373

FDA Product Code

• FTL: Mesh, surgical, polymeric

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: 2024-02-12
• Device Publish Date: 2024-02-04

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• 10884521177727: Self-Gripping Polyester Mesh,Polyester with Polylactic Acid Grips
• 10884521177697: Self-Gripping Polyester Mesh,Right Anatomical, Polyester with Polylactic Acid Grips
• 10884521177680: Self-Gripping Polyester Mesh,Left Anatomical, Polyester with Polylactic Acid Grips
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• 10884521844285: Self-Gripping Polypropylene Mesh Polypropylene with Polylactic Acid Grips
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