Duns Number:447228586
Device Description: DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G X 100 mm, COMPATIBLE AUTOMATIC PROMAG 2.2 ® G DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G X 100 mm, COMPATIBLE AUTOMATIC PROMAG 2.2 ® GUN
Catalog Number
VE1410
Brand Name
FastCutE
Version/Model Number
VE1410
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
0e8cc833-eeab-4055-b2da-2d8c7e0d528a
Public Version Date
May 27, 2021
Public Version Number
2
DI Record Publish Date
April 26, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |