AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197263870)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 320-175-235
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 320-175-235
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197263870
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Kocher Bladder Spatula 23.5cm

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?
33480	Bladder spatula	A hand-held surgical instrument designed to manipulate, typically by lifting, the bladder during a surgical intervention in the abdominal cavity. It typically consists of a large flat blunt blade (no sharp edges) at the distal end that is set at a right angle to the handle and curved so that the surgeon can manipulate the organ from its underside; it has a strong handle at the proximal end. It is usually made of stainless steel and is available in a variety of blade designs (e.g., curved upwards with a flat rounded end). The blade and handle can be designed to be at various ergonomic angles to each other. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGN	RETRACTOR, NON-SELF-RETAINING

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: 2c0a074c-5303-4b4b-81fa-45db8e304dba
Public Version Date: July 08, 2024
Public Version Number: 1
DI Record Publish Date: June 28, 2024