AccessGUDID - DEVICE: ProCare Dent 11 A (04029577154998)

GUDID

Device Identifier (DI) Information

Brand Name: ProCare Dent 11 A
Version or Model: 4029577154998
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Chemische Fabrik Dr. Weigert GmbH & Co. KG

Primary DI Number: 04029577154998
Issuing Agency: GS1
Commercial Distribution End Date: February 03, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 316788397 *Terms of Use

Device Description: No description.

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:	Yes
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?
41654	Dishwasher detergent	A dedicated agent intended to be used in a dish washing machine. It will exert a cleansing and possibly antimicrobial effect through a surface action upon the dishes and cutlery being washed. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLG	Cleaner, Ultrasonic, Medical Instrument

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: 48d06844-0f57-46cd-a31f-02263ffc69e9
Public Version Date: February 13, 2025
Public Version Number: 2
DI Record Publish Date: July 02, 2022