Duns Number:809699023
Device Description: NAMIC Convenience Kit
Catalog Number
-
Brand Name
NAMIC
Version/Model Number
PK232023S
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"
Yes
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
-
Product Code Name
-
Public Device Record Key
4625c23d-ece1-4fb9-9ed2-74a8b170859f
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 06, 2018
Package DI Number
H965PK232023S1
Quantity per Package
10
Contains DI Package
H965PK232023S0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 71 |
2 | A medical device with a moderate to high risk that requires special controls. | 1641 |