SPEAX Trial Package - The Trial Package for the SPEAX Communication - ATAIA INC.

Duns Number:117116534

Device Description: The Trial Package for the SPEAX Communication System, including 1 Communicator and 10 Patc The Trial Package for the SPEAX Communication System, including 1 Communicator and 10 Patches

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More Product Details

Catalog Number

FGN006

Brand Name

SPEAX Trial Package

Version/Model Number

FGN-006

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

9ce1269c-0e44-4845-9ff2-fd3ba633c396

Public Version Date

March 17, 2020

Public Version Number

1

DI Record Publish Date

March 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATAIA INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7