Duns Number:711789789
Catalog Number
-
Brand Name
Single Use Aspiration Needle NA-U401SX
Version/Model Number
NA-U401SX-4022
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"
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
FCG
Product Code Name
Biopsy needle
Public Device Record Key
1366dd32-bf12-483b-acd0-d63e4cb36eb7
Public Version Date
June 21, 2022
Public Version Number
4
DI Record Publish Date
September 07, 2017
Package DI Number
14953170388283
Quantity per Package
5
Contains DI Package
04953170388286
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |