Duns Number:308951313
Device Description: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissu The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy® Biopsy Needle for a Bard® Magnum® or Pro-Mag™ Biopsy Instrument.
Catalog Number
N20418013
Brand Name
M-Biopsy Needle For Reusable Biopsy Instruments
Version/Model Number
N20418013
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
DWO
Product Code Name
Needle, Biopsy, Cardiovascular
Public Device Record Key
ea32d10f-8709-4729-a421-f4f06c83fe71
Public Version Date
August 13, 2019
Public Version Number
1
DI Record Publish Date
August 05, 2019
Package DI Number
05711055001779
Quantity per Package
10
Contains DI Package
15711055001776
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |