Catalog Number

STIX64B

Brand Name

Micro-Stix

Version/Model Number

STIX64B

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)

Yes

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

56a63eba-781d-442e-819b-d34c907506d4

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

December 08, 2020

Package DI Number

20789594000842

Quantity per Package

24

Contains DI Package

10789594000845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case