Skarzynski Piston Titanium 1006055

GUDID EHKM10060551

Ossicular Prosthesis, partial

Heinz Kurz GmbH

Ossicular prosthesis, partial

• Primary Device ID: EHKM10060551
• NIH Device Record Key: 1e809480-94a0-4ba7-a86b-88c4654d5c38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skarzynski Piston Titanium
• Version Model Number: 1006055
• Catalog Number: 1006055
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EHKM10060551 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-21

On-Brand Devices [Skarzynski Piston Titanium ]

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• EHKM10060791: Ossicular Prosthesis, partial
• EHKM10060781: Ossicular Prosthesis, partial
• EHKM10060771: Ossicular Prosthesis, partial
• EHKM10060761: Ossicular Prosthesis, partial
• EHKM10060751: Ossicular Prosthesis, partial
• EHKM10060741: Ossicular Prosthesis, partial
• EHKM10060731: Ossicular Prosthesis, partial
• EHKM10060711: Ossicular Prosthesis, partial
• EHKM10060691: Ossicular Prosthesis, partial
• EHKM10060681: Ossicular Prosthesis, partial
• EHKM10060671: Ossicular Prosthesis, partial
• EHKM10060661: Ossicular Prosthesis, partial
• EHKM10060651: Ossicular Prosthesis, partial
• EHKM10060641: Ossicular Prosthesis, partial
• EHKM10060631: Ossicular Prosthesis, partial
• EHKM10060611: Ossicular Prosthesis, partial
• EHKM10060591: Ossicular Prosthesis, partial
• EHKM10060581: Ossicular Prosthesis, partial
• EHKM10060571: Ossicular Prosthesis, partial
• EHKM10060561: Ossicular Prosthesis, partial
• EHKM10060551: Ossicular Prosthesis, partial
• EHKM10060541: Ossicular Prosthesis, partial
• EHKM10060531: Ossicular Prosthesis, partial