Duns Number:544571975
Device Description: Reusable Needle Guides for use with Wisonic L15-4B, L15-4NB Ultrasound Transducers and BAR Reusable Needle Guides for use with Wisonic L15-4B, L15-4NB Ultrasound Transducers and BARD Needle Guide 900013B01(21G).
Catalog Number
-
Brand Name
InnoFine
Version/Model Number
JSP-010
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
-
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
OIJ
Product Code Name
Biopsy Needle Guide Kit
Public Device Record Key
99e775c8-826b-4a51-853b-3e62461ec09a
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
September 04, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |