GYNECARE VERSAPOINT

Basic Information

• Brand Name: GYNECARE VERSAPOINT
• Primary DI: 10705031000780
• Version / Model: 00467
• Catalog Number: 00467
• 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: 6
• Public Version Date: 2023-11-20
• Public Version Status: Update
• Public Device Record Key: d6ea04f4-1091-4d9f-a55c-2f70fd418b0f
• Distribution End Date: 2021-12-24

Device Description

Electrode - Twizzle Tip. 5Fr (1.6mm nom.) x 360mm.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
61872	Endoscopic electrosurgical electrode, bipolar, single-use	An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031000787	GS1	BOX	5	Not in Commercial Distribution	2021-12-24
Primary	10705031000780	GS1
Package	30705031000784	GS1	CARTON	20	Not in Commercial Distribution	2021-12-24

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K962482	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged