American Medicals

Basic Information

• Brand Name: American Medicals
• Primary DI: B356BD310010
• 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: 2022-09-16
• Public Version: 1
• Public Version Date: 2022-09-26
• Public Version Status: New
• Public Device Record Key: 9ff02a09-3f2b-430f-be64-61095ff56c40

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
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37821	Craniofacial calliper	A hand-held measuring instrument consisting of a Vernier calliper type sliding scale with extra long protruding legs that are used to make facial and cranial measurements to establish the proportions of the facial features and the dimensions of the skull. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B356BD310010	HIBCC