Catalog Number

1051267

Brand Name

D-Speed

Version/Model Number

D-Speed

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

e59a751b-e6c7-45b7-8ecc-73d86991a63f

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Package DI Number

60889971051264

Quantity per Package

50

Contains DI Package

40889971051260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case