Catalog Number

18310-QU

Brand Name

Quala

Version/Model Number

18310-QU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IWZ

Product Code Name

Film, Radiographic

Public Device Record Key

fe587c4c-626e-4545-8896-ee26f5c83fd3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 11, 2017

Package DI Number

D02318310QU32

Quantity per Package

50

Contains DI Package

D02318310QU10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-