AccessGUDID - DEVICE: help:ex discolor f (J009670002000)

GUDID

Device Identifier (DI) Information

Brand Name: help:ex discolor f
Version or Model: 67000200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 67000200
Company Name: Renfert GmbH

Primary DI Number: J009670002000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328502976 *Terms of Use

Device Description: Cleanser for dissolving/removing discoloration such as tar, coffee and tea deposits from dental prostheses, liquid

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):	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?
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUX	Cleanser, Denture, Prescription

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
Storage Environment Temperature: between 41 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00139502-31ea-4dbd-96b3-4b5dba00e0d6
Public Version Date: July 18, 2023
Public Version Number: 1
DI Record Publish Date: July 10, 2023