Upper Eyelid Implant Platinum/Iridium 4007009

GUDID EHKM40070091

Eyelid weight, implantable

Heinz Kurz GmbH

Eyelid weight, implantable

• Primary Device ID: EHKM40070091
• NIH Device Record Key: bd36c5c3-bce1-441a-94e9-b62785ad39c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Upper Eyelid Implant Platinum/Iridium
• Version Model Number: 4007009
• Catalog Number: 4007009
• 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	EHKM40070091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011115

FDA Product Code

• MML: Weights, Eyelid, External

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 [Upper Eyelid Implant Platinum/Iridium ]

• EHKM40070101: Eyelid weight, implantable
• EHKM40070091: Eyelid weight, implantable
• EHKM40070081: Eyelid weight, implantable
• EHKM40070071: Eyelid weight, implantable
• EHKM40070061: Eyelid weight, implantable
• EHKM40070051: Eyelid weight, implantable
• EHKM40070041: Eyelid weight, implantable
• EHKM40070031: Eyelid weight, implantable
• EHKM40070021: Eyelid weight, implantable