Catalog Number

1002481

Brand Name

Henry Schein

Version/Model Number

1002481

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

-

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

EKP

Product Code Name

REAMER, PULP CANAL, ENDODONTIC

Public Device Record Key

30bda428-2ffc-4b2d-8853-e8e7af952ad2

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-