Nucleus - FREEDOM MINI BTE CONTROLLER, BEIGE - COCHLEAR LIMITED

Duns Number:750551194

Device Description: FREEDOM MINI BTE CONTROLLER, BEIGE

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More Product Details

Catalog Number

S50853

Brand Name

Nucleus

Version/Model Number

S50853

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MCM

Product Code Name

IMPLANT, COCHLEAR

Device Record Status

Public Device Record Key

d269aebb-f085-4822-b598-9c1ddea2152d

Public Version Date

December 24, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COCHLEAR LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 18
3 A medical device with high risk that requires premarket approval 980