American Medicals

Basic Information

• Brand Name: American Medicals
• Primary DI: B356KE332160
• 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: 2023-06-21
• Public Version: 1
• Public Version Date: 2023-06-29
• Public Version Status: New
• Public Device Record Key: 5fcf585a-8202-4be8-a3d8-9b6e9599e2e7

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
EMF	Knife, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41544	Periodontal knife	A hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B356KE332160	HIBCC