Duns Number:564251911
Device Description: Content: 1 piece Height: 22 mm
Catalog Number
-
Brand Name
PRETTAU 3 Dispersive A1 98H22 with step
Version/Model Number
ZROC0951A01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
c423d958-d0ce-4704-bffb-e94d3792f970
Public Version Date
April 07, 2021
Public Version Number
1
DI Record Publish Date
March 30, 2021
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 | 1369 |
2 | A medical device with a moderate to high risk that requires special controls. | 4845 |
U | Unclassified | 3 |