Catalog Number

9007414

Brand Name

Henry Schein

Version/Model Number

9007414

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

DZP

Product Code Name

INSTRUMENT, DIAMOND, DENTAL

Public Device Record Key

d3a8219b-e3c2-43d3-b863-c0b4ba7d0fd5

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

December 30, 2019

Package DI Number

20304040035447

Quantity per Package

10

Contains DI Package

10304040035440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-