Catalog Number

9004587

Brand Name

Henry Schein

Version/Model Number

9004587

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DZM

Product Code Name

NEEDLE, DENTAL

Public Device Record Key

e4a82795-3687-4333-9b2d-1d9b3d3e32c9

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

20304040051720

Quantity per Package

500

Contains DI Package

10304040051723

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-