Catalog Number

ASY-00758

Brand Name

Accelus Navigated Reusable Instruments

Version/Model Number

ASY-00758

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

K212088

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

04d4a86c-711c-4f78-be13-d384df502cb4

Public Version Date

May 13, 2022

Public Version Number

2

DI Record Publish Date

March 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-