Duns Number:002064319
Device Description: PREM 100 1/2S 78.6 DWT
Catalog Number
-
Brand Name
NOBILIUM
Version/Model Number
P8S12
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
Yes
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
EJH
Product Code Name
Alloy, Metal, Base
Public Device Record Key
810d948b-c6e8-4d0f-9a24-86e96a472c29
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 07, 2016
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 | 92 |
2 | A medical device with a moderate to high risk that requires special controls. | 2024 |