Catalog Number

610-1339

Brand Name

Astra Vr

Version/Model Number

A9002-01

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150504,K150504

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

afd1b1c7-beab-44ae-a22a-66216674ffa3

Public Version Date

April 09, 2019

Public Version Number

6

DI Record Publish Date

August 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-