VASECTOMY REVERSAL APPROXIMATOR CLAMP

Basic Information

• Brand Name: VASECTOMY REVERSAL APPROXIMATOR CLAMP
• Primary DI: 00192896045644
• Version / Model: 516-742
• Catalog Number: 516-742
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 3
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 3e22b348-77ce-41de-8a15-39dada8fb1c0
• Distribution End Date: 2023-06-21

Device Description

VASECTOMY REVERSAL APPROXIMATOR CLAMP

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", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDJ	CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	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	00192896045644	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2 x 6 Millimeter Tips