Catalog Number

CP3401

Brand Name

Rospital Productos Medicos

Version/Model Number

CP3401

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"

Yes

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

ITG

Product Code Name

Bandage, Cast

Public Device Record Key

aba88f59-61a6-41c7-91f2-837324264ce9

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Package DI Number

10812460028015

Quantity per Package

12

Contains DI Package

00812460028018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER BOX