GORE-TEX Suture 8M06A

GUDID 00733132604791

CV-8 SUTURE 30" PT-13 DA 1 DZ

W. L. Gore & Associates, Inc.

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 00733132604791
• NIH Device Record Key: e6a49715-b03b-444a-82be-524314cf513f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Suture
• Version Model Number: 8M06A
• Catalog Number: 8M06A
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 12
• 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: +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
• 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
• 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
• 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: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter
• Length: 76 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132604791 [Primary]
GS1	00733132629886 [Unit of Use]

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: 4
• Public Version Date: 2019-03-20
• 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