No-Scalpel Vasectomy

Basic Information

• Brand Name: No-Scalpel Vasectomy
• Primary DI: 15055515600292
• Version / Model: 4.0mm kit
• Catalog Number: LV-04K-859
• Company Name: FEMCARE LIMITED
• Labeler DUNS: 500218573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-07
• Public Version: 1
• Public Version Date: 2023-06-15
• Public Version Status: New
• Public Device Record Key: 15c373ec-1e1f-48cb-a28e-13817a187a63

Device Description

No-Scalpel Vasectomy 4.0mm kit

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: Yes
• 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: Yes
• 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
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46417	Urological surgical procedure kit, non-medicated, reusable	A collection of various urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. The kit is not dedicated to a specific type of urological surgical procedure and does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15055515600292	GS1

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	4.0	Millimeter