Duns Number:447228586
Device Description: 10 CS- SEMIAUTOM. NEEDLE 20G X 50mmNOT REPOSITIONABLE FOR MAMMARYNODULE LOCALIZATION, SING 10 CS- SEMIAUTOM. NEEDLE 20G X 50mmNOT REPOSITIONABLE FOR MAMMARYNODULE LOCALIZATION, SINGLE HOOK
Catalog Number
PNA2005
Brand Name
AutoMark
Version/Model Number
PNA2005
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 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
8aaeb024-529a-4f7e-afe3-9c65d5e96248
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
January 05, 2017
Package DI Number
08052440108619
Quantity per Package
10
Contains DI Package
08032986359416
Package Discontinue Date
May 14, 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 |