Duns Number:341086190
Device Description: DTK adhesive refill pack in a double mixing cartridge 1 x 8 g
Catalog Number
54001195
Brand Name
DTK adhesive refill pack
Version/Model Number
54001195
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KOL
Product Code Name
ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPOLYMER
Public Device Record Key
e446629b-181c-40d3-a98d-9691f8c11f30
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
EBRE540011959
Quantity per Package
1
Contains DI Package
EBRE540011950
Package Discontinue Date
September 22, 2016
Package Status
Not in Commercial Distribution
Package Type
dummy
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 375 |