Catalog Number

ROB10000

Brand Name

CORI

Version/Model Number

ROB10000

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

-

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

K193120

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

40ce926b-ce18-4312-846e-9b0151a20fab

Public Version Date

April 20, 2020

Public Version Number

1

DI Record Publish Date

April 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-