AccessGUDID - DEVICE: CariFree Fluoride Varnish (00856596006410)

GUDID

Device Identifier (DI) Information

Brand Name: CariFree Fluoride Varnish
Version or Model: Raspberry
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dental Alliance Holdings LLC

Primary DI Number: 00856596006410
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 195544965 *Terms of Use

Device Description: A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application

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?
35698	Dental cavity varnish	A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	Varnish, Cavity

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: f8abc3c6-9bad-4b74-a552-62d103f16478
Public Version Date: February 17, 2023
Public Version Number: 2
DI Record Publish Date: February 10, 2022