GYNECARE VERSAPOINT

Basic Information

• Brand Name: GYNECARE VERSAPOINT
• Primary DI: 10705031000926
• Version / Model: 01931
• Catalog Number: 01931
• Company Name: ETHICON INC.
• Labeler DUNS: 002144145
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2021-12-16
• Public Version Status: Update
• Public Device Record Key: ed084f9f-3283-437e-b050-896a5b5b14ec
• Distribution End Date: 2021-12-15

Device Description

Resectoscopic System, Working Element, Passive

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: No
• 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
HIH	HYSTEROSCOPE (AND ACCESSORIES)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35043	Electrosurgical handpiece/electrode holder, reusable	A device used to house or fix an active electrosurgical conducting unit (handpiece/pen with its electrode) when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. This device will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705031000926	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, handle with care