Slim HP Color Cap - Velvet Black - Advanced Bionics AG

Duns Number:485262658

Device Description: Velvet Black

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More Product Details

Catalog Number

-

Brand Name

Slim HP Color Cap

Version/Model Number

CI-7131-007

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P960058,P960058

Product Code Details

Product Code

MCM

Product Code Name

Implant, Cochlear

Device Record Status

Public Device Record Key

2b7572e2-ab25-486f-9baf-bb89f1d98b93

Public Version Date

April 08, 2022

Public Version Number

2

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