DIANA SJ1312

GUDID 04047844008393

The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

SIGNUS Medizintechnik GmbH

Sacroiliac joint intra-articular arthrodesis implant

• Primary Device ID: 04047844008393
• NIH Device Record Key: f1934de9-1280-4fdf-93fd-bb990811556d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIANA
• Version Model Number: IF-Screw
• Catalog Number: SJ1312
• Company DUNS: 344203948
• Company Name: SIGNUS Medizintechnik GmbH
• 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

Customer Support Contacts

• Phone: +49602391660
• Email: info@signus.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844008393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091122

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-11
• Device Publish Date: 2015-09-24

On-Brand Devices [DIANA]

• 04047844008423: The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient a
• 04047844008416: The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient a
• 04047844008409: The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient a
• 04047844008393: The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient a
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• 04047844059685: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
• 04047844055885: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p