Duns Number:447228586
Device Description: DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZA DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
Catalog Number
PNA2010
Brand Name
AutoMark
Version/Model Number
PNA2010
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
9ee2b7e6-baf5-46b1-a292-c615fa1a86e2
Public Version Date
June 10, 2022
Public Version Number
3
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 |