Catalog Number

P1834114

Brand Name

Nucleus® Smart App

Version/Model Number

NSA-1 / v5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

P970051

Product Code

MCM

Product Code Name

Implant, cochlear

Public Device Record Key

f52cbe35-a1f4-4c50-b4c6-eeef8dbf6511

Public Version Date

March 25, 2022

Public Version Number

1

DI Record Publish Date

March 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-