Catalog Number

PECGDRCMU

Brand Name

CARDINAL HEALTH

Version/Model Number

PECGDRCMU

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EBO

Product Code Name

Denture repair kit

Public Device Record Key

c5800016-9ad0-4d6b-a018-d12ecb3749eb

Public Version Date

May 07, 2019

Public Version Number

3

DI Record Publish Date

April 26, 2018

Package DI Number

50887488954828

Quantity per Package

1

Contains DI Package

10887488954820

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE