AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197269988)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 350-399-280
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 350-399-280
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197269988
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Braun uterine depressor 28 cm, 11 "

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?
42536	Uterine depressor	A hand-held surgical instrument used to displace (depress -- to press down or aside) the uterus to facilitate examination of the surrounding organs/tissue during a surgical intervention. It is typically a double-ended device, that can be of various shapes (e.g., curved, spoon-shaped, or fenestrated) with the working ends slightly angled to improve organ manipulation and visibility. It is usually made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 9ff431bb-62a5-4212-aa8f-e4aca5afcba4
Public Version Date: July 08, 2024
Public Version Number: 1
DI Record Publish Date: June 28, 2024