Catalog Number

9004098

Brand Name

Henry Schein

Version/Model Number

9004098

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

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Public Device Record Key

219a286c-b658-4703-aac9-0db7a3beb60e

Public Version Date

September 25, 2019

Public Version Number

1

DI Record Publish Date

September 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-