Duns Number:310093901
Device Description: Sterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respective Sterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respectively), each with 9 different inserts for 10-20 gauge needles
Catalog Number
-
Brand Name
Single-Use Needle Guide
Version/Model Number
UA1337
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
K083667,K083667
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
f038aee3-aa8e-4d2d-b980-2107cad4ef28
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
September 17, 2016
Package DI Number
05704916000851
Quantity per Package
9
Contains DI Package
05704916000844
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 |