AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197477697)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 430-355-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 430-355-000
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197477697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Holder for mouth gag, complete 2 bars, plate for mouth gag fixation

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZX	INSTRUMENT, MICROSURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50933c1d-0377-4575-969c-43d3aa2d2fa0
Public Version Date: September 30, 2024
Public Version Number: 1
DI Record Publish Date: September 20, 2024