AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197257558)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 310-141-230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 310-141-230
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197257558
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: MAYO ROBSON ATRAUMATIC Intestinal Clamp 230mm, 9'' atraumatic serration, curved elastic

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?
64147	Surgical gastrointestinal clamp	A manual, clip-like, surgical device designed specifically to clamp tissues of the gastrointestinal tract (e.g., colon) during open surgery; it does not have handles (i.e., not forceps-like) and is not intended for general manipulation/dissection of tissues. It may be referred to as a Demartel-Wolfson Clamp and is designed with blades hinged at one end and with a locking bar at the other. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXD	CLAMP

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: ca902081-eef9-4d33-907c-a8cdc48ffcdf
Public Version Date: July 08, 2024
Public Version Number: 1
DI Record Publish Date: June 28, 2024