Catalog Number

-

Brand Name

REMI Robotic Navigation System

Version/Model Number

1035

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

K202184

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

78674e6b-c1b9-47a7-bcca-2f5f9bb0bf87

Public Version Date

November 17, 2021

Public Version Number

4

DI Record Publish Date

August 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-