Titanium-Vocal-Fold-Medial-Implant 5001001

GUDID EHKM50010011

Preformed vocal cord medialization implant

Heinz Kurz GmbH

Preformed vocal cord medialization implant

• Primary Device ID: EHKM50010011
• NIH Device Record Key: 6f55a23d-fc84-448d-b4da-3d396e2e73e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titanium-Vocal-Fold-Medial-Implant
• Version Model Number: 5001001
• Catalog Number: 5001001
• 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	EHKM50010011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991324

FDA Product Code

• KHJ: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

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 [Titanium-Vocal-Fold-Medial-Implant ]

• EHKM50010031: Preformed vocal cord medialization implant
• EHKM50010011: Preformed vocal cord medialization implant
• EHKM50010001: Preformed vocal cord medialization implant