Duns Number:006309355
Device Description: Denticator Pick-A-Dent, reusable plastic toothpick
Catalog Number
621714
Brand Name
Denticator
Version/Model Number
621714
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JET
Product Code Name
PICK, MASSAGING
Public Device Record Key
008fa200-4557-4bc6-bfe9-ffaa3df45c42
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302736217149
Quantity per Package
144
Contains DI Package
00302736217142
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Package
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 138 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |