Duns Number:054326178
Device Description: Oral Hygiene Kit, Suction Swabs with Antiseptic Oral Rinse and Mouth Moisturizer
Catalog Number
6115
Brand Name
Toothette Oral Care
Version/Model Number
6115
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
a5d0b078-33f7-4cfc-81e4-5580d108b2d1
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50618029821008
Quantity per Package
100
Contains DI Package
00618029821003
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |