GORE-TEX Suture Oral Health

GUDID H373P5K17A3D

CV-5 SUTURE 61 CM RT-16 1 DOZ.

W. L. Gore & Associates, Inc.

Polytetrafluoroethylene suture Polytetrafluoroethylene suture

• Primary Device ID: H373P5K17A3D
• NIH Device Record Key: 5485bb05-56d3-4cac-82e5-88bf7b8bfafa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Suture Oral Health
• Version Model Number: P5K17A
• 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 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

Device Dimensions

• Length: 61 Centimeter
• Length: 61 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132607624 [Primary]
GS1	00733132628506 [Unit of Use]
HIBCC	H373P5K17A3D [Secondary]

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 Oral Health]

• H373P7K13A3B: CV-7 SUTURE 24" RT-11 SA 1DZ
• H373P6K25A3D: CV-6 SUTURE 61 CM RH-16 1 DOZ.
• H373P6K23A3B: CV-6 SUTURE 61 CM RT-13 1-DOZ.
• H373P5K23A3A: CV-5 SUTURE 61 CM RT-18 1 DOZ.
• H373P5K17A3D: CV-5 SUTURE 61 CM RT-16 1 DOZ.
• 00733132607686: CV-7 SUTURE 24" RT-11 SA 1DZ
• 00733132607679: CV-6 SUTURE 61 CM RH-16 1 DOZ.
• 00733132607662: CV-6 SUTURE 61 CM RT-13 1-DOZ.
• 00733132607648: CV-5 SUTURE 61 CM RT-18 1 DOZ.
• 00733132607624: CV-5 SUTURE 61 CM RT-16 1 DOZ.