Retention Guard Suture Retention Plates - 3"

Basic Information

• Brand Name: Retention Guard Suture Retention Plates - 3"
• Primary DI: 10810805000214
• Version / Model: RG-3
• Company Name: PRESERVATION SOLUTIONS INC
• Labeler DUNS: 090266979
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-12-07
• Public Version: 1
• Public Version Date: 2019-01-07
• Public Version Status: New
• Public Device Record Key: 839cd54c-54d0-4ffd-9fa8-dbba7480f048

Device Description

For the temporary, external anchoring of sutures and prevention of suture pull through.

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: 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
Primary	10810805000214	GS1
Unit of Use	00810805000217	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]