Catalog Number

01GS90

Brand Name

Guardian Unity

Version/Model Number

01GS90

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K020637

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

773fe51f-005d-401d-abde-ba7f88116a77

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

April 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-