AccessGUDID - DEVICE: Philips Sonicare BreathRx (00075020048059)

GUDID

Device Identifier (DI) Information

Brand Name: Philips Sonicare BreathRx
Version or Model: DIS359/03
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Discus Dental, LLC

Primary DI Number: 00075020048059
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 831726109 *Terms of Use

Device Description: No description.

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):	Yes
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: c76d3d96-b954-4ad6-b789-688204fcb74c
Public Version Date: January 31, 2024
Public Version Number: 3
DI Record Publish Date: August 28, 2020