PEAK MEDICAL

Basic Information

• Brand Name: PEAK MEDICAL
• Primary DI: G453521053112M0
• Version / Model: 52105-31-12M
• Company Name: Peak Medical Distribution Inc.
• Labeler DUNS: 078393632
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-01
• Public Version: 1
• Public Version Date: 2025-10-09
• Public Version Status: New
• Public Device Record Key: c8dd67ce-aa8f-4422-bcc5-bae12ae792c3

Device Description

5mm, 37.5cm Working Length, Closed, Angled Tear Drop Shaped Tip, Knot Pusher, CM Markings, 3mm Oval Suture hole, "M" 6 sided Handle - Reusable - Stainless Steel.

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47462	Suture knot-tying device	A sterile surgical instrument designed to automatically tie a self-locking, sliding, surgical knot into a delivered suture during open surgery. The knot is subsequently advanced using standard techniques. The instrument is a hand-operated device with an internal mechanism configured to create the knot when the loose ends of the suture are placed into it. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G453521053112M0	HIBCC