mahe medical GmbH

Basic Information

• Brand Name: mahe medical GmbH
• Primary DI: 04050659364585
• Version / Model: 30.019.052QL
• Company Name: mahe medical gmbh
• Labeler DUNS: 342243334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-05
• Public Version: 1
• Public Version Date: 2019-11-13
• Public Version Status: New
• Public Device Record Key: a5ea2264-9702-4261-9142-c01cd7108da3

Device Description

Outer sheath f.OP-cont.flow Hyst.sheath,_x000D_wl: 192mm, dropshaped, 1 valve 5mm _x000D_

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: Yes

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
37084	Rigid endoscope telescope	An optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050659364585	GS1