Wax Coated Braided Silk

Wax Coated Braided Silk
Sofsilk - S-317

A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

• diameter,1,N/A;
• Length: 30 Inch

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GAP

Device Name: Suture, Nonabsorbable, Silk

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: 878.5030

Third Party Flag: N

Medical Specialty: SU

Device Id: 20884521086514

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521086517

Package Quantity: 24

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521086517

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