SUTUREGARD(R) Hammerhead(TM) Adhesive Suture Retention Device

Basic Information

• Brand Name: SUTUREGARD(R) Hammerhead(TM) Adhesive Suture Retention Device
• Primary DI: 00860007834240
• Version / Model: 1
• Catalog Number: HRD001-H
• Company Name: SUTUREGARD MEDICAL, INC
• Labeler DUNS: 080072274
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-03
• Public Version: 1
• Public Version Date: 2025-10-13
• Public Version Status: New
• Public Device Record Key: e31b4673-e375-49f7-bd37-5f770609f264

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
Package	10860007834247	GS1	Box	12	In Commercial Distribution
Primary	00860007834240	GS1

Customer Contacts

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