Unitron Brand - Insera B7-312 - Sonova AG

Duns Number:480662550

Device Description: Insera B7-312

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More Product Details

Catalog Number

-

Brand Name

Unitron Brand

Version/Model Number

063-6312-01

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)

-

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

OSM

Product Code Name

Hearing Aid, Air Conduction With Wireless Technology

Device Record Status

Public Device Record Key

0ab764f1-cf7e-4fb8-a525-8fbd6bd4137e

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONOVA AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 103
2 A medical device with a moderate to high risk that requires special controls. 2466