Bard® Goodwin Sounds

Basic Information

• Brand Name: Bard® Goodwin Sounds
• Primary DI: 00801741047213
• Version / Model: 042800
• Catalog Number: 042800
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-18
• Public Version: 3
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: fcf3039f-3774-47fc-a185-ac5f3054d3dd

Device Description

Bard Goodwin Urethral Sound Complete Set 12 thru 30 Fr., Non-Sterile

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FBX	SOUND, URETHRAL, METAL OR PLASTIC	Gastroenterology, Urology	876.5520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11265	Urethral dilator, reusable	A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741047213	GS1

Customer Contacts

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