Duns Number:135057938
Device Description: BARD® Coaxial Biopsy Needle to be used with BARD® MAGNUM® Biopsy Instrument and Biopsy Nee BARD® Coaxial Biopsy Needle to be used with BARD® MAGNUM® Biopsy Instrument and Biopsy Needles, 13g x 10cm
Catalog Number
AX1413
Brand Name
BARD®
Version/Model Number
AX1413
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)
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
6f6a6664-43a0-435d-99a2-2fbc7a0d5c54
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
September 13, 2016
Package DI Number
10801741084819
Quantity per Package
10
Contains DI Package
00801741084812
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |