Duns Number:317654283
Device Description: Disposable Biopsy Needle with Marker Plates; For Re-Order: 41779B (5 pcs of 41778B) Disposable Biopsy Needle with Marker Plates; For Re-Order: 41779B (5 pcs of 41778B)
Catalog Number
41778B
Brand Name
Disposable Biopsy Needle
Version/Model Number
41778B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
6e4c7e0d-35e7-471d-a5a0-815062cda257
Public Version Date
March 16, 2021
Public Version Number
3
DI Record Publish Date
August 30, 2016
Package DI Number
14048223028657
Quantity per Package
5
Contains DI Package
04048223028643
Package Discontinue Date
March 15, 2025
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |