Catalog Number

39567

Brand Name

Mi1250 SYNCHRONY 2 COMPRESSED S-Vector Magnet

Version/Model Number

39539

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

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

1a1e1cb6-6793-497b-9ae0-42c4c4f3d9ba

Public Version Date

May 13, 2022

Public Version Number

3

DI Record Publish Date

December 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-