Cochlear - CP1000 Processing Unit Bulk, Brown - COCHLEAR LIMITED

Duns Number:750551194

Device Description: CP1000 Processing Unit Bulk, Brown

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More Product Details

Catalog Number

P732099

Brand Name

Cochlear

Version/Model Number

P732099

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

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

dbb995ff-fe7d-483b-8a6f-9d1cc238ae35

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

July 07, 2017

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