Catalog Number

-

Brand Name

RONDO Control Unit anthracite, SP

Version/Model Number

35068

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P000025,P000025

Product Code

MCM

Product Code Name

Implant, Cochlear

Public Device Record Key

9f6f9ddc-7607-42b5-aea3-f54c7c934b6b

Public Version Date

July 22, 2022

Public Version Number

3

DI Record Publish Date

June 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-