Catalog Number

-

Brand Name

SONNET 2 Me1510 (w/o Magnet RCB) white

Version/Model Number

40088

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,P000025,P000025

Product Code

MCM

Product Code Name

Implant, Cochlear

Public Device Record Key

745738c1-08b1-44e0-b817-9e19aeda99ac

Public Version Date

April 13, 2022

Public Version Number

4

DI Record Publish Date

October 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-