Duns Number:807404611
Catalog Number
FN18-51T
Brand Name
FN NEEDLES
Version/Model Number
FN18-51T
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
K071550,K071550
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
95051b5f-f9fc-4bef-847e-52c0fc637bb1
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
February 19, 2016
Package DI Number
20790986006298
Quantity per Package
10
Contains DI Package
10790986006291
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 461 |