USA Elite

Basic Information

• Brand Name: USA Elite
• Primary DI: 00821925002678
• Version / Model: K-SE
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 3
• Public Version Date: 2023-07-24
• Public Version Status: Update
• Public Device Record Key: f18be898-e558-4613-89ee-43363af725a3

Device Description

USA Elite System and USA Series Cold Knife, Serrated Blade

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
EZO	Urethrotome	Gastroenterology, Urology	876.4770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17633	Urethrotome	A surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925002678	GS1
Unit of Use	00821925038417	GS1