Relate3.1 Gold RIC 312 - Relate3.1 Gold RIC 312 (sand) - Sonova AG

Duns Number:480662550

Device Description: Relate3.1 Gold RIC 312 (sand)

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More Product Details

Catalog Number

050-6403-R876

Brand Name

Relate3.1 Gold RIC 312

Version/Model Number

050-6403-R876

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

OSM

Product Code Name

Hearing Aid, Air Conduction With Wireless Technology

Device Record Status

Public Device Record Key

3ae079d8-e655-4186-a919-a2c84915c3a9

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 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