Catalog Number

K5402901

Brand Name

QAWeb Enterprise

Version/Model Number

V2.xx

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LHO

Product Code Name

Instrument, quality-assurance, radiologic

Public Device Record Key

c3d24150-7a48-4f60-bac2-0ddcfb42703d

Public Version Date

April 28, 2021

Public Version Number

2

DI Record Publish Date

July 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-