PEAK MEDICAL

Basic Information

• Brand Name: PEAK MEDICAL
• Primary DI: G453332786800
• Version / Model: 3327-8680
• Company Name: Peak Medical Distribution Inc.
• Labeler DUNS: 078393632
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-01
• Public Version: 1
• Public Version Date: 2023-05-09
• Public Version Status: New
• Public Device Record Key: 1b7e7ea1-253a-40dd-b5dc-9cdf4c456a08
• Distribution End Date: 2023-05-01

Device Description

Retrograde Valvulotomes Blade 9.5"

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
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14339	Valvulotome	A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G453332786800	HIBCC