NiTiFLEX Nitinol/Titanium 1007259

GUDID EHKM10072591

Ossicular Prosthesis, partial

Heinz Kurz GmbH

Ossicular prosthesis, partial

• Primary Device ID: EHKM10072591
• NIH Device Record Key: fd8e3d8d-07ad-47cd-8320-681a11d2ccac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NiTiFLEX Nitinol/Titanium
• Version Model Number: 1007259
• Catalog Number: 1007259
• 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	EHKM10072591 [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 [NiTiFLEX Nitinol/Titanium ]

• EHKM10072611: Ossicular Prosthesis, partial
• EHKM10072591: Ossicular Prosthesis, partial
• EHKM10072581: Ossicular Prosthesis, partial
• EHKM10072571: Ossicular Prosthesis, partial
• EHKM10072561: Ossicular Prosthesis, partial
• EHKM10072551: Ossicular Prosthesis, partial
• EHKM10072541: Ossicular Prosthesis, partial
• EHKM10072531: Ossicular Prosthesis, partial
• EHKM10072111: Ossicular Prosthesis, partial
• EHKM10072091: Ossicular Prosthesis, partial
• EHKM10072081: Ossicular Prosthesis, partial
• EHKM10072071: Ossicular Prosthesis, partial
• EHKM10072061: Ossicular Prosthesis, partial
• EHKM10072051: Ossicular Prosthesis, partial
• EHKM10072041: Ossicular Prosthesis, partial
• EHKM10072031: Ossicular Prosthesis, partial