Penile Clamp

Basic Information

• Brand Name: Penile Clamp
• Primary DI: 00801741050961
• Version / Model: 600404
• Catalog Number: 600404
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 1
• Public Version Date: 2020-09-30
• Public Version Status: New
• Public Device Record Key: a445ada8-f9f5-4e63-a3f9-f505b85be1c7

Device Description

Penile Clamp, Zipser

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FHA	CLAMP, PENILE	Gastroenterology, Urology	876.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42797	Incontinence penis clamp, reusable	A male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder. It is typically made of plastic materials and is designed as an adjustable, two-hinged, self-retaining lever clamp with foam rubber inserts; the user can typically adjust the tension to suit their penis size and needs. It is removed by the user when voiding and then reapplied. The device is washed/disinfected at regular intervals to maintain hygiene. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741050961	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry and clean environment