Catalog Number

-

Brand Name

EXCELSIUS GPS

Version/Model Number

6143.2564

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171651

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

50ef788a-eea1-4a3b-8343-7b4436f9d049

Public Version Date

July 05, 2019

Public Version Number

1

DI Record Publish Date

June 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-