Greenwald Surgical Company, Inc.

Basic Information

• Brand Name: Greenwald Surgical Company, Inc.
• Primary DI: 10801334005559
• Version / Model: 50510-01
• Catalog Number: U467VR
• Company Name: GRACE MANUFACTURING, INC.
• Labeler DUNS: 607903382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 066e49f7-aed0-4673-990b-97fc81f10900

Device Description

Urethrotome Round Blade Cold Knife. Compatible with ACMI USA/Elite visual urethrotome.

Device Characteristics

• Single Use: No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Liquid Chemical", "Moist Heat or Steam Sterilization"]

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	10801334005559	GS1