American Orthopaedic™

Basic Information

• Brand Name: American Orthopaedic™
• Primary DI: 04042809241594
• Version / Model: 74470-16
• Catalog Number: 74470-16
• Company Name: BSN MEDICAL, INC.
• Labeler DUNS: 026301221
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-27
• Public Version: 2
• Public Version Date: 2022-12-05
• Public Version Status: Update
• Public Device Record Key: ac542c29-0e2f-4850-af8a-05ed9f69d207

Device Description

1 VACUUM, 115V CAST DUST AM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGH	INSTRUMENT, CAST REMOVAL, AC-POWERED	Orthopedic	888.5960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45590	Cast cutter vacuum system	An assembly of devices designed to collect the dust produced by a cast cutter (e.g., pneumatic or electric cast saw) from the workspace environment by suction during the cast removal procedure. It typically consists of a motorized vacuum pump, a filter, and a collection container (e.g., bag or cartridge). It is typically a portable unit and its motor may run concurrently with the saw motor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04042809241594	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]