GORE-TEX Suture 0N08

GUDID 00733132626113

CV-0 SUTURE 36"THX-36 DA

W. L. Gore & Associates, Inc.

Polytetrafluoroethylene suture

• Primary Device ID: 00733132626113
• NIH Device Record Key: bb8ed9cc-6f9c-4c2d-9e37-b9988e8a3cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Suture
• Version Model Number: 0N08
• Catalog Number: 0N08
• 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 n
• 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(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
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter
• Length: 91 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600144 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	00733132600151 [Package]; Package: [36 Units]; In Commercial Distribution
GS1	00733132626113 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE-TEX Suture]

• 00733132629954: CV-6 SUTURE 61CM RT-13 SA Oral Health
• 00733132629947: CV-8 SUTURE 30"TTC-13 DA
• 00733132629930: CV-6 SUTURE 61CM RH-16 SA Oral Health
• 00733132629923: CV-5 SUTURE 61CM RT-18 SA Oral Health
• 00733132629916: CV-4 SUTURE 61CM RT-18 SA Oral Health
• 00733132629909: CV-2 SUTURE 48"PS-4 THX-26 DA
• 00733132629893: CV-8 SUTURE 30"PT-09 DA
• 00733132629886: CV-8 SUTURE 30"PT-13 DA
• 00733132629879: CV-8 SUTURE 30"TTC-09 DA
• 00733132629862: CV-8 SUTURE 24"TTC-07 DA
• 00733132629855: CV-8 SUTURE 24"PT-09 DA
• 00733132629848: CV-8 SUTURE 24"TTC-09 DA
• 00733132629831: CV-8 SUTURE 18" TTC-09 DA
• 00733132629824: CV-7 SUTURE 30"TTC-12 DA
• 00733132629817: CV-7 SUTURE 30"THC-13 DA
• 00733132629800: CV-7 SUTURE 30"PT-13 DA
• 00733132629794: CV-7 SUTURE 30"TTC-13 DA
• 00733132629787: CV-7 SUTURE 30"PT-09 DA
• 00733132629770: CV-7 SUTURE 30"TTC-09 DA
• 00733132629763: CV-7 SUTURE 24"PT-13 DA
• 00733132629756: CV-7 SUTURE 24"TTC-13 DA
• 00733132629749: CV-7 SUTURE 24"PT-09 DA
• 00733132629466: CV-7 SUTURE 24"TTC-09 DA
• 00733132629459: CV-7 SUTURE 18"THC-13 DA
• 00733132629442: CV-7 SUTURE 18"TTC-13 DA
• 00733132629435: CV-7 SUTURE 18"PT-09 DA
• 00733132629428: CV-7 SUTURE 18"TTC-09 DA
• 00733132629411: CV-6 SUTURE 36"TH-18 DA
• 00733132629404: CV-6 SUTURE 36"TTC-13 DA
• 00733132629398: CV-6 SUTURE 30"THc-09 DA
• 00733132629381: CV-6 SUTURE 30"PH-13 DA
• 00733132629374: CV-6 SUTURE 30"THC-13 DA
• 00733132629367: CV-6 SUTURE 30"TTC-12 DA
• 00733132629350: CV-6 SUTURE 30"PT-13 DA
• 00733132629343: CV-6 SUTURE 30"PT-09 DA
• 00733132629336: CV-6 SUTURE 30"TTC-13 DA
• 00733132629329: CV-6 SUTURE 30"TTC-09 DA
• 00733132629176: CV-6 SUTURE 18"TTC-13 DA
• 00733132629169: CV-6 SUTURE 18"TTC-09 DA
• 00733132629152: CV-5 SUTURE 36"TH-26 DA
• 00733132629145: CV-5 SUTURE 36"PH-17 DA
• 00733132629138: CV-5 SUTURE 36"THC-13 DA
• 00733132629121: CV-5 SUTURE 36"PT-17 DA
• 00733132629114: CV-5 SUTURE 36"PT-13 DA
• 00733132629107: CV-5 SUTURE 36" TT-17 DA
• 00733132629091: CV-5 SUTURE 36"TH-18 DA
• 00733132629084: CV-5 SUTURE 36"TTC-13 DA
• 00733132629077: CV-5 SUTURE 30"PH-13 DA
• 00733132629060: CV-5 SUTURE 30"THC-13 DA
• 00733132629053: CV-5 SUTURE 30"TTC-13 DA