Duns Number:447228586
Device Description: NOT REPOSITIONABLE NEEDLE20G X 120mm FOR MAMMARY NODULESLOCALIZATION WITH DOUBLE HOOK
Catalog Number
PNX2012
Brand Name
Mark
Version/Model Number
PNX2012
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
GDF
Product Code Name
Guide, Needle, Surgical
Public Device Record Key
077940a7-fb6f-469e-ad21-37557917524f
Public Version Date
May 27, 2021
Public Version Number
6
DI Record Publish Date
June 05, 2017
Package DI Number
08058341214022
Quantity per Package
10
Contains DI Package
08052440107490
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 |