Catalog Number

55BHW

Brand Name

ORTHO CP-GU M

Version/Model Number

ORTHO CP-GU M 15x30

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)

Yes

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

76b48408-9957-44b5-930e-741dd1dc33a0

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

July 29, 2022

Package DI Number

05414904220863

Quantity per Package

5

Contains DI Package

05414904197561

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-