Catalog Number

-

Brand Name

QudraView

Version/Model Number

100

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

-

Product Code

NNI

Product Code Name

Container, Specimen, Non-Sterile

Public Device Record Key

c800bf68-9462-4d19-8111-77d1becee8c5

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

May 03, 2021

Package DI Number

16973166110030

Quantity per Package

10

Contains DI Package

06973166110033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-