Duns Number:310093901
Device Description: Sterile-packed. Extended. Bore diameter 1.6mm; angle of insertion 17.7° to the long axis o Sterile-packed. Extended. Bore diameter 1.6mm; angle of insertion 17.7° to the long axis of the transducer
Catalog Number
-
Brand Name
Extended, Single-Use Biopsy Guide
Version/Model Number
UA1257-S17E
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
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
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
c2ec10d3-d878-4dcd-88a9-a48b2b947740
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
September 17, 2016
Package DI Number
05704916000714
Quantity per Package
18
Contains DI Package
05704916000707
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |