Rexton - Rexton HA RX ACCORD 16 2C P BG Hearing Aid - SIVANTOS, INC.

Duns Number:157412271

Device Description: Rexton HA RX ACCORD 16 2C P BG Hearing Aid

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More Product Details

Catalog Number

10822836

Brand Name

Rexton

Version/Model Number

HA RX ACCORD 16 2C P BG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 27, 2020

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

b7db0221-7577-4256-8eab-ab2bd573dd9d

Public Version Date

November 30, 2020

Public Version Number

4

DI Record Publish Date

May 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIVANTOS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1885
2 A medical device with a moderate to high risk that requires special controls. 5568