Catalog Number

-

Brand Name

Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clamp

Version/Model Number

JINTMAP1136

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

K192663

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

612a834e-1f94-48ce-89da-79c2908bd8d0

Public Version Date

November 22, 2021

Public Version Number

1

DI Record Publish Date

November 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-