Regensburg Type Total Titanium 1004458

GUDID EHKM10044581

Ossicular Prosthesis, total

Heinz Kurz GmbH

Ossicular prosthesis, total

• Primary Device ID: EHKM10044581
• NIH Device Record Key: fd15618c-1a97-42c5-b4d3-40c115083b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regensburg Type Total Titanium
• Version Model Number: 1004458
• Catalog Number: 1004458
• 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	EHKM10044581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972585

FDA Product Code

• ETA: Replacement, Ossicular Prosthesis, Total

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 [Regensburg Type Total Titanium]

• EHKM10044621: Ossicular Prosthesis, total
• EHKM10044611: Ossicular Prosthesis, total
• EHKM10044601: Ossicular Prosthesis, total
• EHKM10044591: Ossicular Prosthesis, total
• EHKM10044581: Ossicular Prosthesis, total