Catalog Number

55BPC

Brand Name

Ortho CP-GU M

Version/Model Number

ORTHO CP-GU M 18x43

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

c24562b2-4100-4a6e-b5cf-28f7402d3abc

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

05414904220719

Quantity per Package

5

Contains DI Package

05414904198032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-