Duns Number:002863526
Device Description: Elevate Tongue Cleaner Metal Green w/Pink and Blue Bands
Catalog Number
-
Brand Name
Elevate Tongue Cleaner Metal Green w/Pink and Blue Bands
Version/Model Number
655METGRN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
LCN
Product Code Name
Scraper, Tongue
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |