Catalog Number

9007984

Brand Name

Henry Schein

Version/Model Number

9007984

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

EKF

Product Code Name

INSTRUMENT, CONTOURING, MATRIX, OPERATIVE

Public Device Record Key

cd4ea4a3-8ad0-46c9-8192-f1f29022d305

Public Version Date

June 06, 2019

Public Version Number

1

DI Record Publish Date

May 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-