AccessGUDID - DEVICE: COMBIDRIVE EN (04055207001530)

GUDID

Device Identifier (DI) Information

Brand Name: COMBIDRIVE EN
Version or Model: 409001202
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 40900.1202
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207001530
Issuing Agency: GS1
Commercial Distribution End Date: June 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SPRAY ATTACHMENT for CombiDrive EN Motor Control Unit, for Clean Spray for cleaning of the micro motor

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
37412	Medical device cleaning jet handpiece	A hand-operated device designed to regulate and direct a narrow stream (a jet) of water and/or air for the initial cleaning of laboratory glassware, pipettes, syringes, certain endoscopes, cannulae, surgical instruments and other devices prior to disinfection/sterilization. It is usually in the form of a pistol with an activation trigger, and may be fitted with different nozzles or a variable nozzle. It is typically connected via tubing to a tap (faucet) and/or a pressurized air source. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 0ef6f3ce-db2d-4805-913c-c411158fe865
Public Version Date: May 29, 2023
Public Version Number: 6
DI Record Publish Date: July 21, 2017