POLYGLYTONE 6211

Basic Information

• Brand Name: POLYGLYTONE 6211
• Primary DI: 04026704603909
• Version / Model: IPN000862
• Catalog Number: 833-135
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 3
• Public Version Date: 2019-01-15
• Public Version Status: Update
• Public Device Record Key: a4ac03b5-df92-427b-884f-5cea082879bd

Device Description

Polyglytone 6211 Size 2-0 36" CST-43 Needle T Needle BSC

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57991	Polyglytone suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polyglytone 6211 (a polyester composed of glycolide, caprolactone, trimethylene carbonate, and lactide) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues, including use in ophthalmic surgery but not for cardiovascular/neurological surgery and microsurgery; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704603903	GS1	Box	12	Not in Commercial Distribution	2019-01-15
Primary	04026704603909	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Suture Length 36", Needle 1 Length 1.030", Needle 2 Length 0.156"

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store at room temperature