NiTiBOND Nitinol/Titanium 1007154

GUDID EHKM10071541

Ossicular Prosthesis, partial

Heinz Kurz GmbH

Ossicular prosthesis, partial

• Primary Device ID: EHKM10071541
• NIH Device Record Key: 7bd8d9cf-8d34-4544-8897-906a8a2be8bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NiTiBOND Nitinol/Titanium
• Version Model Number: 1007154
• Catalog Number: 1007154
• 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	EHKM10071541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112616

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

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• EHKM10071591: Ossicular Prosthesis, partial
• EHKM10071581: Ossicular Prosthesis, partial
• EHKM10071571: Ossicular Prosthesis, partial
• EHKM10071561: Ossicular Prosthesis, partial
• EHKM10071551: Ossicular Prosthesis, partial
• EHKM10071541: Ossicular Prosthesis, partial
• EHKM10071531: Ossicular Prosthesis, partial
• EHKM10071111: Ossicular Prosthesis, partial
• EHKM10071091: Ossicular Prosthesis, partial
• EHKM10071081: Ossicular Prosthesis, partial
• EHKM10071071: Ossicular Prosthesis, partial
• EHKM10071061: Ossicular Prosthesis, partial
• EHKM10071051: Ossicular Prosthesis, partial
• EHKM10071041: Ossicular Prosthesis, partial
• EHKM10071031: Ossicular Prosthesis, partial