Catalog Number

5444

Brand Name

The Wand Universal Needle Guide Probe Cover Kit

Version/Model Number

5444

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"

Yes

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

K970889,K973958,K970889,K973958

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

0ef01dc5-1060-4a58-8c49-64dc0b75e5f2

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

10841912101457

Quantity per Package

10

Contains DI Package

00841912101450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-