Silk

Basic Information

• Brand Name: Silk
• Primary DI: 10790986006901
• Version / Model: 1862S
• Company Name: C.P. MEDICAL CORPORATION
• Labeler DUNS: 807404611
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-21
• Public Version: 5
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 1f36c0c7-91e2-42d5-871a-ae24375d53d1

Device Description

1/0 Silk, 18" Non-Needled

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: No
• 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
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	878.5030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13910	Silk suture	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20790986006762	GS1		12	In Commercial Distribution
Primary	10790986006901	GS1