PTFE Polymer Pledgets

Basic Information

• Brand Name: PTFE Polymer Pledgets
• Primary DI: 10884521550698
• Version / Model: VPG36SE
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 8
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 9f0e9937-e9ff-4396-b997-2f2acb836827

Device Description

Nonabsorbable Pledgets, 10x Soft Pledgets 3x6x1.65mm

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: No
• 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
GAT	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13906	Polyester suture, non-bioabsorbable, multifilament	A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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
Package	20884521550695	GS1	PACK_OR_INNER_PACK	36	In Commercial Distribution
Primary	10884521550698	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K930591	000