Catalog Number

1067529

Brand Name

T-MAT H/RA

Version/Model Number

T-MAT H/RA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2018

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

efa88b7f-5e4f-499c-a5ed-943f002b4afb

Public Version Date

May 21, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

60889971067524

Quantity per Package

10

Contains DI Package

40889971067520

Package Discontinue Date

May 15, 2018

Package Status

Not in Commercial Distribution

Package Type

Case