Catalog Number

1118348

Brand Name

HALF Blue X-ray Film WB

Version/Model Number

HALF Blue X-ray Film WB

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)

-

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

08b8f287-e6cc-4fb6-94b7-2af6849c6a5a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

60889971118349

Quantity per Package

5

Contains DI Package

40889971118345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case