Duns Number:310093901
Device Description: Sterile packed. Accepts needles 10-20 gauge; angle of insertion 30° to the image axis
Catalog Number
-
Brand Name
Single-Use Needle Guide
Version/Model Number
UA1335
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
2a9a10f0-647c-49c1-9ec1-cd066e6d51e1
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
September 17, 2016
Package DI Number
05704916000813
Quantity per Package
9
Contains DI Package
05704916000806
Package Discontinue Date
December 31, 2018
Package Status
Not 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 |