GORE-TEX Suture Oral Health

Basic Information

• Brand Name: GORE-TEX Suture Oral Health
• Primary DI: 00733132607648
• Version / Model: P5K23A
• Catalog Number: P5K23A
• Company Name: W. L. Gore & Associates, Inc.
• Labeler DUNS: 967358115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 8
• Public Version Date: 2023-12-22
• Public Version Status: Update
• Public Device Record Key: 2f56f20c-d780-4e00-8836-478a8424b61e

Device Description

GORE-TEX SUTURE CV-5 61cm RT-18-1dz

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAW	SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE	General, Plastic Surgery	878.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13909	Polyolefin/fluoropolymer suture, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733132607648	GS1
Unit of Use	00733132629923	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P820083	025

Device Sizes

Type	Value	Unit	Text
Length	61	Centimeter