Duns Number:631734758
Device Description: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spri Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 17.1 cm.
Catalog Number
SG13-171
Brand Name
Gangi-SoftGuard Coaxial Needle
Version/Model Number
SG13-171
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K181756,K181756,K181756
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
7e21f212-aa3b-493c-a560-b9d1bc419ac5
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
January 21, 2019
Package DI Number
27350031351235
Quantity per Package
12
Contains DI Package
17350031351238
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Transportation box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |