Catalog Number

-

Brand Name

SPHERZ: ILUMARK TWIST 2020-05

Version/Model Number

2020-05

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

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

9397787a-9292-417a-afdc-7e9328e12e80

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-