MatriX SlimLine Stapes Prosthesis Titanium - Ossicular Prosthesis, partial - Heinz Kurz GmbH

Duns Number:341155720

Device Description: Ossicular Prosthesis, partial

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More Product Details

Catalog Number

1006289

Brand Name

MatriX SlimLine Stapes Prosthesis Titanium

Version/Model Number

1006289

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

Yes

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

K130512

Product Code Details

Product Code

ETB

Product Code Name

Prosthesis, Partial Ossicular Replacement

Device Record Status

Public Device Record Key

c53d18c9-e388-489f-b42b-69e3340ec399

Public Version Date

October 29, 2021

Public Version Number

1

DI Record Publish Date

October 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEINZ KURZ GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 333