Catalog Number

75009257

Brand Name

PIGALILEO

Version/Model Number

75009257

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

K061362

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

fa2bda5a-f08a-4292-b2d6-6b5d4ce8ac43

Public Version Date

October 18, 2021

Public Version Number

3

DI Record Publish Date

November 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-