Duns Number:447228586
Device Description: GUILLOTINE NEEDLE 18G X 250MMFOR SOFT TISSUE BIOPSY FOR MAGNUMBARD TM AND PALIUM GUN,WITH GUILLOTINE NEEDLE 18G X 250MMFOR SOFT TISSUE BIOPSY FOR MAGNUMBARD TM AND PALIUM GUN,WITH COAXIAL
Catalog Number
MGC1825
Brand Name
FastCutM
Version/Model Number
MGC1825
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2021
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"
-
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
MJG
Product Code Name
Device, Percutaneous, Biopsy
Public Device Record Key
f9a2d279-4e87-4100-aa2f-f1bd932fb457
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
February 21, 2017
Package DI Number
08058341218907
Quantity per Package
10
Contains DI Package
08032986351533
Package Discontinue Date
April 26, 2021
Package Status
Not 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 | 228 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 138 |