Absorbable Wound Closure Device

Absorbable Wound Closure Device
Syneture - VLOCN2147

A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. It does not include antimicrobial agents/materials. This is a single-use device.

• Length: 9 Inch
• diameter,1,N/A;

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: 20884521762586

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521762589

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521762589

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