American Medicals

Basic Information

• Brand Name: American Medicals
• Primary DI: B356CD475180
• Version / Model: 1
• Company Name: American Medicals
• Labeler DUNS: 109909627
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-06
• Public Version: 1
• Public Version Date: 2022-09-14
• Public Version Status: New
• Public Device Record Key: 6951238f-f11d-4173-90d8-36fc83891126

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Microwave Radiation

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62471	Coronary artery clamp	A hand-held, manual surgical instrument designed to directly compress a coronary artery during coronary artery graft surgery to create a temporary atraumatic haemostasis (arrest or prevention of bleeding). It may be referred to as a clip or a clamp, is made of plastic, and has a self-retaining design; it is not in the form of a bulldog clamp nor scissors-like forceps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B356CD475180	HIBCC