ViO - VIO T42 FW 1.0.0 - Sbo Hearing A/S

Duns Number:306018410

Device Description: VIO T42 FW 1.0.0

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More Product Details

Catalog Number

-

Brand Name

ViO

Version/Model Number

220344

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KLW

Product Code Name

Masker, tinnitus

Device Record Status

Public Device Record Key

5c8a8ffe-d0f0-443e-9ca2-3137a6ca2958

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SBO HEARING A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 2842