Catalog Number

-

Brand Name

STRYKER SPHERES -100CT

Version/Model Number

8000-100-004

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K022074,K022074

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

6569ba7a-7ec1-4dad-b544-feadd167e068

Public Version Date

August 11, 2022

Public Version Number

2

DI Record Publish Date

October 13, 2021

Package DI Number

00815212024474

Quantity per Package

100

Contains DI Package

00815212024528

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack