Catalog Number

-

Brand Name

coDiagnostiX

Version/Model Number

10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DZJ

Product Code Name

Driver, Wire, And Bone Drill, Manual

Public Device Record Key

ac3a6117-0d8b-4a10-a84e-69b15af5d97c

Public Version Date

July 27, 2022

Public Version Number

2

DI Record Publish Date

July 20, 2021

Package DI Number

D835CODX200

Quantity per Package

1

Contains DI Package

D835CODX1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-