AccessGUDID - DEVICE: Elevate Tongue Cleaner Metal Green w/Pink and Blue Bands (00858290006642)

GUDID

Device Identifier (DI) Information

Brand Name: Elevate Tongue Cleaner Metal Green w/Pink and Blue Bands
Version or Model: 655METGRN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELEVATE ORAL CARE, LLC

Primary DI Number: 00858290006642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002863526 *Terms of Use

Device Description: Elevate Tongue Cleaner Metal Green w/Pink and Blue Bands

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?
16308	Tongue scraper, single-use	A non-sterile device designed 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 plastic and is available in a variety of designs (e.g., a U-shaped band or a T-shaped instrument), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a single-use 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: d5567d62-d009-4efc-a809-9bfd84a7358b
Public Version Date: August 05, 2021
Public Version Number: 1
DI Record Publish Date: July 28, 2021