Catalog Number

W3US01

Brand Name

geko

Version/Model Number

W-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

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

K220327,K220327,K220327

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

88c3be8e-8a7f-404c-8325-0fee97ed88b0

Public Version Date

June 22, 2022

Public Version Number

1

DI Record Publish Date

June 14, 2022

Package DI Number

05060294771616

Quantity per Package

7

Contains DI Package

05060294771609

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wallet