Catalog Number

55749-02

Brand Name

REgistration Matrix CT Small Incision Spine

Version/Model Number

55749-02

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

-

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

66270727-1aec-4edb-8e19-e530618d66c3

Public Version Date

March 24, 2021

Public Version Number

4

DI Record Publish Date

December 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-