Duns Number:140727624
Device Description: Pro-Mag™ "Short Throw" Biopsy Needle 18ga x 16cm
Catalog Number
765118160
Brand Name
Pro-Mag™ "Short Throw" Biopsy Needle
Version/Model Number
765118160
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
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
40b82781-2d61-4bc1-9cbe-fa467ebf4030
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
20886333222968
Quantity per Package
10
Contains DI Package
00886333222964
Package Discontinue Date
-
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 | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |