Catalog Number

DX-22-300

Brand Name

CORUS Spinal System-X

Version/Model Number

DX-22-300

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

K190201,K190201

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

18b6219f-bc4a-4e49-8790-bf2e24e24552

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 12, 2020

Package DI Number

10852776006505

Quantity per Package

1

Contains DI Package

00852776006508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box