ValveGate™ Endoscope 5mm, direction of view 30°, autoclavable, 30cm

Basic Information

• Brand Name: ValveGate™ Endoscope 5mm, direction of view 30°, autoclavable, 30cm
• Primary DI: 04057034117071
• Version / Model: 34-0961.AC
• Catalog Number: 34-0961.AC
• Company Name: Geister Medizintechnik GmbH
• Labeler DUNS: 343548848
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2018-10-19
• Public Version Status: Update
• Public Device Record Key: 9e3f36bc-cd10-4968-86f6-3e321caa8196

Device Description

ValveGate™ Endoscope 5mm, direction of view 30°, autoclavable, 30cm

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32043	Laparoscopic surgical procedure kit, non-medicated, reusable	A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04057034117071	GS1

Customer Contacts

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