Catalog Number

-

Brand Name

All-in-one computer + Pre-installed Software

Version/Model Number

ACC00008

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

K190929

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

b5221840-ac67-4141-b401-9c865b098b0b

Public Version Date

March 24, 2020

Public Version Number

1

DI Record Publish Date

March 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-