RZ Medizintechnik GmbH

Basic Information

• Brand Name: RZ Medizintechnik GmbH
• Primary DI: 04049197477697
• Version / Model: 430-355-000
• Catalog Number: 430-355-000
• Company Name: RZ-Medizintechnik GmbH
• Labeler DUNS: 312953227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-20
• Public Version: 1
• Public Version Date: 2024-09-30
• Public Version Status: New
• Public Device Record Key: 50933c1d-0377-4575-969c-43d3aa2d2fa0

Device Description

Holder for mouth gag, complete 2 bars, plate for mouth gag fixation

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: Yes
• 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
GZX	INSTRUMENT, MICROSURGICAL	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63854	Mouth gag support, reusable	A non-sterile frame-like device intended to support a mouth gag over/near a patient’s mouth during dental, anaesthesia, or ENT procedures. It consists of three interlocking components: a strip with a central line of holes and two rods with rings at one end which can be aligned to accept the supporting hook of the mouth gag. Otherwise known as a Draffin Bipod, the arrangement provides a configurable support at variable heights. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049197477697	GS1

Customer Contacts

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