K-Piston Titanium 1006116

GUDID EHKM10061161

Ossicular Prosthesis, partial

Heinz Kurz GmbH

Ossicular prosthesis, partial

• Primary Device ID: EHKM10061161
• NIH Device Record Key: e1abfe79-3db0-49f4-b9d3-d300a8c92dd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Piston Titanium
• Version Model Number: 1006116
• Catalog Number: 1006116
• 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	EHKM10061161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002221

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 [K-Piston Titanium ]

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• EHKM10061661: Ossicular Prosthesis, partial
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• EHKM10061621: Ossicular Prosthesis, partial
• EHKM10061611: Ossicular Prosthesis, partial
• EHKM10061601: Ossicular Prosthesis, partial
• EHKM10061591: Ossicular Prosthesis, partial
• EHKM10061581: Ossicular Prosthesis, partial
• EHKM10061571: Ossicular Prosthesis, partial
• EHKM10061561: Ossicular Prosthesis, partial
• EHKM10061551: Ossicular Prosthesis, partial
• EHKM10061541: Ossicular Prosthesis, partial
• EHKM10061531: Ossicular Prosthesis, partial
• EHKM10061201: Ossicular Prosthesis, partial
• EHKM10061181: Ossicular Prosthesis, partial
• EHKM10061161: Ossicular Prosthesis, partial
• EHKM10061141: Ossicular Prosthesis, partial
• EHKM10061121: Ossicular Prosthesis, partial
• EHKM10061111: Ossicular Prosthesis, partial
• EHKM10061101: Ossicular Prosthesis, partial
• EHKM10061091: Ossicular Prosthesis, partial
• EHKM10061081: Ossicular Prosthesis, partial
• EHKM10061071: Ossicular Prosthesis, partial
• EHKM10061061: Ossicular Prosthesis, partial
• EHKM10061051: Ossicular Prosthesis, partial
• EHKM10061041: Ossicular Prosthesis, partial
• EHKM10061031: Ossicular Prosthesis, partial