AccessGUDID - DEVICE: Freshmint (00085317005665)

GUDID

Device Identifier (DI) Information

Brand Name: Freshmint
Version or Model: DA24
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEW WORLD IMPORTS, INC.

Primary DI Number: 00085317005665
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075372276 *Terms of Use

Device Description: Freshmint® 2 oz Denture Adhesive, Zinc Free, Extra Strength holding power with easy open cap

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?
46127	Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free	An adhesive compound composed of carboxymethylcellulose sodium and a polymer (e.g., ethylene oxide homopolymer, cationic polyacrylamide polymer, polyvinyl methylether maleic acid salt), that does not contain zinc (i.e., no zinc salts), intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOO	Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

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: 9e47bee1-cd55-4990-b4e8-b0690955e46e
Public Version Date: August 19, 2020
Public Version Number: 1
DI Record Publish Date: August 11, 2020