Catalog Number

10823133

Brand Name

Rexton

Version/Model Number

HA RX ACCORD 12 2C P SLV - DGT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 27, 2020

Issuing Agency

In GS1

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

OSM

Product Code Name

Hearing Aid, Air Conduction With Wireless Technology

Public Device Record Key

da7388c3-f5ca-405b-8126-31190497ef81

Public Version Date

November 30, 2020

Public Version Number

4

DI Record Publish Date

May 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-