Catalog Number

1125316

Brand Name

Henry Schein

Version/Model Number

1125316

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

b930ffac-4e2c-44eb-b72c-cd7c04aeebe1

Public Version Date

April 11, 2019

Public Version Number

1

DI Record Publish Date

April 03, 2019

Package DI Number

20304040040960

Quantity per Package

10

Contains DI Package

10304040040963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

1125316