Catalog Number

907004-001

Brand Name

Esteem® Sensor

Version/Model Number

7004

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

P090018,P090018,P090018

Product Code

OAF

Product Code Name

Implant, Hearing, Active, Middle Ear, Totally Implanted

Public Device Record Key

ba0de6c4-d07f-4f3c-ad55-12a55d0071d2

Public Version Date

December 21, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-