Catalog Number

279726500

Brand Name

EXPEDIUM

Version/Model Number

279726500

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

KIH

Product Code Name

DISPENSER, CEMENT

Public Device Record Key

56a1fe8b-f82e-4e38-b2b8-b46a2870abd9

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

May 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-