Duns Number:004193103
Device Description: Transform Tray Sample Pack (1x MU + 1x ML) - Dentate
Catalog Number
118200
Brand Name
Astek
Version/Model Number
118200
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
EHY
Product Code Name
TRAY, IMPRESSION, PREFORMED
Public Device Record Key
f0290089-f7e3-4547-97a3-0f07de11d7ec
Public Version Date
October 26, 2022
Public Version Number
1
DI Record Publish Date
October 18, 2022
Package DI Number
15060111782341
Quantity per Package
2
Contains DI Package
05060111782344
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 | 77 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |