MatriX Offset Stapes Prothesis Titanium 1006034

GUDID EHKM10060341

Ossicular Prosthesis, partial

Heinz Kurz GmbH

Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial

• Primary Device ID: EHKM10060341
• NIH Device Record Key: 0cb9abd1-1801-4221-89c3-a11d3571ff11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MatriX Offset Stapes Prothesis Titanium
• Version Model Number: 1006034
• Catalog Number: 1006034
• Company DUNS: 341155720
• Company Name: Heinz Kurz GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com
• Phone: +49707291790
• Email: info@kurzmed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EHKM10060341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130512

FDA Product Code

• ETB: Prosthesis, Partial Ossicular Replacement

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-29
• Device Publish Date: 2021-10-21

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• EHKM10022731 - CliP Partial Prosthesis Titanium: 2023-10-09 Ossicular Prosthesis, partial
• EHKM10022741 - CliP Partial Prosthesis Titanium: 2023-10-09 Ossicular Prosthesis, partial