UNIFY PGA Surgical Sutures

Basic Information

• Brand Name: UNIFY PGA Surgical Sutures
• Primary DI: 00814639021097
• Version / Model: S-G418R13-U
• Company Name: APPLIED DENTAL, INC.
• Labeler DUNS: 017524666
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 60adf4a5-994f-44ab-82c5-e7f3d5701402

Device Description

UNIFY PGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13908	Polyglycolic acid suture	A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. 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	10814639021094	GS1	box	12	In Commercial Distribution
Primary	00814639021097	GS1
Package	20814639021091	GS1	case	100	In Commercial Distribution

Customer Contacts

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