Elevate Tongue Cleaner Metal 6pk - Elevate Tongue Cleaner Metal 6pk - ELEVATE ORAL CARE, LLC

Duns Number:002863526

Device Description: Elevate Tongue Cleaner Metal 6pk

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More Product Details

Catalog Number

-

Brand Name

Elevate Tongue Cleaner Metal 6pk

Version/Model Number

655METAL6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LCN

Product Code Name

Scraper, Tongue

Device Record Status

Public Device Record Key

9f63ef3a-0484-4750-894b-76108885cdbc

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELEVATE ORAL CARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 20
U Unclassified 5