GLYCOLON

Basic Information

• Brand Name: GLYCOLON
• Primary DI: E203USPB41506
• Version / Model: GLYCOLON
• Company Name: Resorba Medical GmbH
• Labeler DUNS: 341053195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-17
• Public Version: 3
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: 474b76d9-63b3-4f2b-b68c-01d53b2a0ccd

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
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17246	Polyglyconate suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from polyglyconate (prepared from a copolymer of glycolic acid and trimethylene carbonate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (especially in paediatric cardiovascular surgeries). It may include an attached needle intended to be disposed of after single use. The thread provides extended 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
Primary	E203USPB41506	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K143584	000