Catalog Number

FGN002

Brand Name

SPEAX Patch

Version/Model Number

FGN-002

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

373849ec-060f-466d-b4c9-858e9ea0b11f

Public Version Date

February 11, 2022

Public Version Number

2

DI Record Publish Date

March 09, 2020

Package DI Number

B792FGN003

Quantity per Package

10

Contains DI Package

B792FGN002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

white cardboard box