Greenwald Surgical Company, Inc.

Basic Information

• Brand Name: Greenwald Surgical Company, Inc.
• Primary DI: 10801334008079
• Version / Model: 51900-18
• Catalog Number: U419
• Company Name: GRACE MANUFACTURING, INC.
• Labeler DUNS: 607903382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2dca1f61-39f2-4722-9be4-2a63f876fdb5

Device Description

Otis bougie-a-boule. stainless steel

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: ["Moist Heat or Steam Sterilization", "Liquid Chemical"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAX	Bougie, Urological	Gastroenterology, Urology	876.5520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14286	Urethral bougie, reusable	A rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10801334008079	GS1

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	18	French