Catalog Number

-

Brand Name

iFuse Implant System-Navigation – Impactor/Removal Adapter

Version/Model Number

400195

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

3c43c744-8580-4cd0-975c-60032deb7fba

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

November 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-