GORE-TEX Suture 2U22

GUDID 00733132628643

CV-2 SUTURE 48" PS-4 DA 1DZ

W. L. Gore & Associates, Inc.

Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 00733132628643
• NIH Device Record Key: 3175cada-ee4d-4847-baed-7a4f160cb321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Suture
• Version Model Number: 2U22
• Catalog Number: 2U22
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, 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: true
• 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(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132602551 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	00733132628643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P820083

FDA Product Code

• GAW: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2024-11-08
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE-TEX Suture]

• 00733132628643: CV-2 SUTURE 48" PS-4 DA 1DZ
• 00733132629312: GORE-TEX SUTURE CV-6 61cm DoubleArm THc-13-1dz
• 00733132629305: GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-12-1dz
• 00733132629299: GORE-TEX SUTURE CV-6 61cm DoubleArm PT-13-1dz
• 00733132629282: GORE-TEX SUTURE CV-6 61cm DoubleArm PT-9-1dz
• 00733132629275: GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-13-1dz
• 00733132629268: GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-9-1dz
• 00733132629251: GORE-TEX SUTURE CV-6 61cm SingleArm TTc-9-1dz
• 00733132629244: GORE-TEX SUTURE CV-6 46cm DoubleArm THc-13-1dz