Resectoscopy working unit,passive, closed handle,19/22Ch

Basic Information

• Brand Name: Resectoscopy working unit,passive, closed handle,19/22Ch
• Primary DI: EMAH36005050
• Version / Model: 36.005.05
• Catalog Number: 36.005.05
• Company Name: mahe medical gmbh
• Labeler DUNS: 342243334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b7236311-4586-47e6-8b9e-a916602df92a

Device Description

Resectoscopy working unit,passive, closed handle,19/22Ch

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: Yes
• 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
FDC	RESECTOSCOPE, WORKING ELEMENT	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37085	Rigid endoscope working guide	An endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EMAH36005051	HIBCC		1	In Commercial Distribution
Primary	EMAH36005050	HIBCC

Customer Contacts

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