Catalog Number

FGN004

Brand Name

SPEAX Starter Package

Version/Model Number

FGN-004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 09, 2022

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

-

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

e91b4d69-b28b-4a2c-959e-3116542d1e9f

Public Version Date

February 11, 2022

Public Version Number

2

DI Record Publish Date

March 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-