TRUGLYDE

TRUGLYDE - 2E70EZ26.5-6

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.

• Diameter : 325 micron or 0.325 mm
• 2-0 USP or 3 metric

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GAM

Device Name: Suture, Absorbable, Synthetic, Polyglycolic Acid

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 878.4493

Third Party Flag: N

Medical Specialty: SU

Device Id: 08903837040619

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 18903837040616

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 08903837040619

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A