mahe medical GmbH

Basic Information

• Brand Name: mahe medical GmbH
• Primary DI: 04050659368941
• Version / Model: 35.010.017
• 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: 08a6bd8e-4cc3-4f22-9db2-aa6e24159b58

Device Description

Flexible foreign body fcps.,alligator, _x000D_7Fr.,400mm _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
FCL	FORCEPS, BIOPSY, NON-ELECTRIC	Gastroenterology, Urology	876.1075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38810	Flexible endoscopic biopsy forceps, reusable	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050659368941	GS1