AccessGUDID - DEVICE: Plastic Tongue Cleaners (00723896023679)

GUDID

Device Identifier (DI) Information

Brand Name: Plastic Tongue Cleaners
Version or Model: 53c2008a
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2039715
Company Name: PRACTICON, INC.

Primary DI Number: 00723896023679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Single piece of plastic with a handle and a head used to scrape tongue for oral hygiene. 100 pack

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?
42538	Tongue scraper, reusable	A device used to scrape the upper surface of the tongue to promote oral hygiene (e.g., to remove plaque, food debris, and bacteria, and to prevent bad breath). It is normally available [non-prescription] over-the-counter (OTC). It is typically made of copper (Cu) because of its biostatic properties (i.e., bacteria will not grow on its surface), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCN	Scraper, Tongue

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: eee61473-cfb7-4b96-a5d6-56d3aff2ed55
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023