Vent. Tube Diabolo Type Gold Platinum 1015053

GUDID EHKM10150531

Middle ear implantable mould

Heinz Kurz GmbH

Middle ear moulding

• Primary Device ID: EHKM10150531
• NIH Device Record Key: edd5716e-e351-4a8d-b67d-504906fcb46c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vent. Tube Diabolo Type Gold Platinum
• Version Model Number: 1015053
• Catalog Number: 1015053
• 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	EHKM10150531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973226

FDA Product Code

• ETD: Tube, Tympanostomy

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 [Vent. Tube Diabolo Type Gold Platinum ]

• EHKM10150551: Middle ear implantable mould
• EHKM10150531: Middle ear implantable mould
• EHKM10150511: Middle ear implantable mould