AccessGUDID - DEVICE: Dale Scrape-n-Suction Tongue Cleaner (00817612021008)

GUDID

Device Identifier (DI) Information

Brand Name: Dale Scrape-n-Suction Tongue Cleaner
Version or Model: 220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 220
Company Name: Dale Medical Products, Inc.

Primary DI Number: 00817612021008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001061233 *Terms of Use

Device Description: The Dale Scrape-n-Suction Tongue Cleaner is a plastic device with a hollow core that allows it to be attached to a vacuum source to remove biofilm from the tongue.

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":	Yes
For Single-Use:	Yes
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: 713ff3d3-52e3-4530-ae39-9ecca1c24a95
Public Version Date: January 08, 2025
Public Version Number: 2
DI Record Publish Date: December 02, 2024