Catalog Number

PECGDRCMT

Brand Name

CARDINAL HEALTH

Version/Model Number

PECGDRCMT

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

d0dadb0c-a9c3-44e7-bbe8-3bcdf1929787

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

December 18, 2017

Package DI Number

50887488844747

Quantity per Package

1

Contains DI Package

10887488844749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE