Catalog Number

650-023

Brand Name

Viewing Wand Cover

Version/Model Number

650-023

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)

Yes

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

K970513,K970513

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

988b7801-0f6b-48a5-a5ff-7cf9ac9e54e3

Public Version Date

September 06, 2021

Public Version Number

4

DI Record Publish Date

August 22, 2017

Package DI Number

00841436106030

Quantity per Package

30

Contains DI Package

10841436106037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-