Slim HP Standard Magnet - 2 - Advanced Bionics AG

Duns Number:485262658

Device Description: 2

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More Product Details

Catalog Number

-

Brand Name

Slim HP Standard Magnet

Version/Model Number

CI-7524-002

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"

-

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

P960058

Product Code Details

Product Code

MCM

Product Code Name

Implant, Cochlear

Device Record Status

Public Device Record Key

66a7161a-6ccf-4cd6-81af-897a808a5d3c

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

February 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED BIONICS AG" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 842