Hansaton - sound XC 5-R312 (sterling silver) - Hansaton Akustik GmbH

Duns Number:316040146

Device Description: sound XC 5-R312 (sterling silver)

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More Product Details

Catalog Number

050-6181-U4

Brand Name

Hansaton

Version/Model Number

050-6181-U4

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

71551dbd-84d1-42cb-9b9c-316f30ea6931

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

March 19, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANSATON AKUSTIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 887