Catalog Number

-

Brand Name

MAXUM

Version/Model Number

M5300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P010023

Product Code

MPV

Product Code Name

Implant, Hearing, Active, Middle Ear, Partially Implanted

Public Device Record Key

ca032b39-7715-4b35-81e1-3f56840076ee

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 03, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-