American Medicals

Basic Information

• Brand Name: American Medicals
• Primary DI: B35674360150
• 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: 2022-09-08
• Public Version: 1
• Public Version Date: 2022-09-16
• Public Version Status: New
• Public Device Record Key: 9516356f-dd67-444f-a1fb-8fda7b3a8bcb

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
HRR	Scissors, Orthopedic, Surgical	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42943	Nail splitting forceps, reusable	A hand-held manual instrument designed to cut and split a fingernail or toenail, typically for removal, during a surgical intervention. It comprises two pivoted blades with curved handles and is operated by forcing the lower blade under the nail to be cut and closing the blades together over the nail in a side-cutting action. The cutting blades are typically short and slender. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B35674360150	HIBCC