Duns Number:153454736
Catalog Number
-
Brand Name
PREMIOtitan
Version/Model Number
TI-10
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
EJH
Product Code Name
Alloy, Metal, Base
Public Device Record Key
cbe7d1a1-79e3-42f6-959b-57b5f7f2c23c
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 28, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 177 |
U | Unclassified | 3 |