SUTUREGARD Intraoperative Skin Relaxation Device

Basic Information

• Brand Name: SUTUREGARD Intraoperative Skin Relaxation Device
• Primary DI: 00860007834219
• Version / Model: 1
• Company Name: Suturegard Medical Inc
• Labeler DUNS: 080072274
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-18
• Public Version: 1
• Public Version Date: 2021-11-26
• Public Version Status: New
• Public Device Record Key: a7ecfc5c-22da-4717-a5c3-6b960c9f2526

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: Yes
• 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
KGS	Retention Device, Suture	General, Plastic Surgery	878.4930	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33519	Suture retention device	A device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860007834216	GS1	Box	12	In Commercial Distribution
Primary	00860007834219	GS1