Catalog Number

FGN010

Brand Name

SPEAX Patch for Home Use

Version/Model Number

FGN-010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

Yes

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

-

Product Code

ILQ

Product Code Name

System, Communication, Powered

Public Device Record Key

f4f86017-1d4c-453a-b749-0a276743bcb9

Public Version Date

May 17, 2022

Public Version Number

2

DI Record Publish Date

January 26, 2022

Package DI Number

B792FGN014

Quantity per Package

5

Contains DI Package

B792FGN010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

white cardboard box