GIZA 48291422S

GUDID 07640167930036

The GIZA is a spinal vertebral body replacement device.

Eden Spine Europe SA

Vertebral body prosthesis

• Primary Device ID: 07640167930036
• NIH Device Record Key: 45a29816-92cf-4f96-9e2d-e8dc06c0f152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIZA
• Version Model Number: Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5
• Catalog Number: 48291422S
• Company DUNS: 482797425
• Company Name: Eden Spine Europe SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167930036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112429

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-24

On-Brand Devices [GIZA]

• 07640167930463: Orthopaedic manual surgical instrument.
• 07640167930456: Orthopaedic manual surgical instrument.
• 07640167930449: Orthopaedic manual surgical instrument.
• 07640167930432: Orthopaedic manual surgical instrument.
• 07640167930425: Orthopaedic manual surgical instrument.
• 07640167930418: Orthopaedic manual surgical instrument.
• 07640167930401: Orthopaedic manual surgical instrument.
• 07640167930395: Orthopaedic manual surgical instrument.
• 07640167930388: Orthopaedic manual surgical instrument.
• 07640167930371: Orthopaedic manual surgical instrument.
• 07640167930364: Orthopaedic manual surgical instrument.
• 07640167930357: Orthopaedic manual surgical instrument.
• 07640167930340: Orthopaedic manual surgical instrument.
• 07640167930333: Orthopaedic manual surgical instrument.
• 07640167930326: Orthopaedic manual surgical instrument.
• 07640167930319: The GIZA is a spinal vertebral body replacement device.
• 07640167930302: The GIZA is a spinal vertebral body replacement device.
• 07640167930296: The GIZA is a spinal vertebral body replacement device.
• 07640167930289: The GIZA is a spinal vertebral body replacement device.
• 07640167930272: The GIZA is a spinal vertebral body replacement device.
• 07640167930265: The GIZA is a spinal vertebral body replacement device.
• 07640167930197: Orthopaedic manual surgical instrument.
• 07640167930180: Orthopaedic manual surgical instrument.
• 07640167930173: Orthopaedic manual surgical instrument.
• 07640167930166: Orthopaedic manual surgical instrument.
• 07640167930159: Orthopaedic manual surgical instrument.
• 07640167930142: Orthopaedic manual surgical instrument.
• 07640167930135: Orthopaedic manual surgical instrument.
• 07640167930128: Orthopaedic manual surgical instrument.
• 07640167930111: Orthopaedic manual surgical instrument.
• 07640167930104: Orthopaedic manual surgical instrument.
• 07640167930098: Orthopaedic manual surgical instrument.
• 07640167930081: Orthopaedic manual surgical instrument.
• 07640167930074: Orthopaedic manual surgical instrument.
• 07640167930067: The GIZA is a spinal vertebral body replacement device.
• 07640167930050: The GIZA is a spinal vertebral body replacement device.
• 07640167930043: The GIZA is a spinal vertebral body replacement device.
• 07640167930036: The GIZA is a spinal vertebral body replacement device.
• 07640167930029: The GIZA is a spinal vertebral body replacement device.
• 07640167930012: The GIZA is a spinal vertebral body replacement device.