Duns Number:310093901
Device Description: Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transd Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transducer
Catalog Number
-
Brand Name
Single-Use Endfire Biopsy Guide
Version/Model Number
UA1323-S
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
45c7864e-576b-4017-a63f-668b87183f60
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
September 17, 2016
Package DI Number
05704916000776
Quantity per Package
18
Contains DI Package
05704916000769
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 |