Catalog Number

291784

Brand Name

Micro-Stix

Version/Model Number

291784

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

EJB

Product Code Name

HANDLE, INSTRUMENT, DENTAL

Public Device Record Key

4623f980-042b-4e46-b8f1-98f282ac1aeb

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

December 08, 2020

Package DI Number

20789594000989

Quantity per Package

350

Contains DI Package

10789594000982

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case