Duns Number:532176000
Device Description: 5 identical cartridges sealed in a vacuum bag ;cartridge dimensions : 28mm diameter ; 84mm 5 identical cartridges sealed in a vacuum bag ;cartridge dimensions : 28mm diameter ; 84mm long ;each cartridge filled with 31Gr of T-Crystal Opaque Pink Thermoplastic pellets.
Catalog Number
112809-05
Brand Name
T-Crystal cartridges Opaque Pink
Version/Model Number
28mm Diam. Large 84mm long
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
Yes
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
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
a32d0528-748c-4b46-9439-a178b0d4ba6e
Public Version Date
June 25, 2020
Public Version Number
1
DI Record Publish Date
June 17, 2020
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |