AccessGUDID - DEVICE: MARK3 (D79616830)

GUDID

Device Identifier (DI) Information

Brand Name: MARK3
Version or Model: 1683
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CARGUS INTERNATIONAL, INC

Primary DI Number: D79616830
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 096191093 *Terms of Use

Device Description: Enamel Care 5% Sodium Fluoride Varnish w/ Calcium & Phosphate Mint 50/bx. - MARK3

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?
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: 043d196c-9191-4d1e-a28c-7e93b4c335b4
Public Version Date: July 09, 2021
Public Version Number: 1
DI Record Publish Date: July 01, 2021