Spinal Fusion Cage System DPUA-40J8

GUDID 08800033390534

4CIS® Dunes PEEK DLIF Cage 10, 40x18x8mm

ALPHANOX CO.,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08800033390534
• NIH Device Record Key: cf7a4e22-0b1a-4755-85b6-f7c6a30baf5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal Fusion Cage System
• Version Model Number: DPUA-40J8
• Catalog Number: DPUA-40J8
• Company DUNS: 687844241
• Company Name: ALPHANOX CO.,LTD.
• 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: false
• 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	08800033390534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190563

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

[08800033390534]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-29
• Device Publish Date: 2024-02-22

On-Brand Devices [Spinal Fusion Cage System]

• 08800033391760: 4CIS® Dunes PEEK DLIF Cage 12, 60x22x20mm
• 08800033391753: 4CIS® Dunes PEEK DLIF Cage 12, 60x22x18mm
• 08800033391746: 4CIS® Dunes PEEK DLIF Cage 12, 60x22x16mm
• 08800033391739: 4CIS® Dunes PEEK DLIF Cage 12, 60x22x14mm
• 08800033391722: 4CIS® Dunes PEEK DLIF Cage 12, 60x22x12mm
• 08800033391715: 4CIS® Dunes PEEK DLIF Cage 12, 60x22x10mm
• 08800033391708: 4CIS® Dunes PEEK DLIF Cage 12, 60x22x8mm
• 08800033391692: 4CIS® Dunes PEEK DLIF Cage 12, 60x18x20mm
• 08800033391685: 4CIS® Dunes PEEK DLIF Cage 12, 60x18x18mm
• 08800033391678: 4CIS® Dunes PEEK DLIF Cage 12, 60x18x16mm
• 08800033391661: 4CIS® Dunes PEEK DLIF Cage 12, 60x18x14mm
• 08800033391654: 4CIS® Dunes PEEK DLIF Cage 12, 60x18x12mm
• 08800033391647: 4CIS® Dunes PEEK DLIF Cage 12, 60x18x10mm
• 08800033391630: 4CIS® Dunes PEEK DLIF Cage 12, 60x18x8mm
• 08800033391623: 4CIS® Dunes PEEK DLIF Cage 12, 55x22x20mm
• 08800033391616: 4CIS® Dunes PEEK DLIF Cage 12, 55x22x18mm
• 08800033391609: 4CIS® Dunes PEEK DLIF Cage 12, 55x22x16mm
• 08800033391593: 4CIS® Dunes PEEK DLIF Cage 12, 55x22x14mm
• 08800033391586: 4CIS® Dunes PEEK DLIF Cage 12, 55x22x12mm
• 08800033391579: 4CIS® Dunes PEEK DLIF Cage 12, 55x22x10mm
• 08800033391562: 4CIS® Dunes PEEK DLIF Cage 12, 55x22x8mm
• 08800033391555: 4CIS® Dunes PEEK DLIF Cage 12, 55x18x20mm
• 08800033391548: 4CIS® Dunes PEEK DLIF Cage 12, 55x18x18mm
• 08800033391531: 4CIS® Dunes PEEK DLIF Cage 12, 55x18x16mm
• 08800033391524: 4CIS® Dunes PEEK DLIF Cage 12, 50x22x20mm
• 08800033391517: 4CIS® Dunes PEEK DLIF Cage 12, 50x22x18mm
• 08800033391500: 4CIS® Dunes PEEK DLIF Cage 12, 50x22x16mm
• 08800033391494: 4CIS® Dunes PEEK DLIF Cage 12, 50x22x14mm
• 08800033391487: 4CIS® Dunes PEEK DLIF Cage 12, 50x22x12mm
• 08800033391470: 4CIS® Dunes PEEK DLIF Cage 12, 50x22x10mm
• 08800033391463: 4CIS® Dunes PEEK DLIF Cage 12, 50x22x8mm
• 08800033391456: 4CIS® Dunes PEEK DLIF Cage 12, 50x18x20mm
• 08800033391449: 4CIS® Dunes PEEK DLIF Cage 12, 50x18x18mm
• 08800033391432: 4CIS® Dunes PEEK DLIF Cage 12, 50x18x16mm
• 08800033391425: 4CIS® Dunes PEEK DLIF Cage 12, 45x22x20mm
• 08800033391418: 4CIS® Dunes PEEK DLIF Cage 12, 45x22x18mm
• 08800033391401: 4CIS® Dunes PEEK DLIF Cage 12, 45x22x16mm
• 08800033391395: 4CIS® Dunes PEEK DLIF Cage 12, 45x22x14mm
• 08800033391388: 4CIS® Dunes PEEK DLIF Cage 12, 45x22x12mm
• 08800033391371: 4CIS® Dunes PEEK DLIF Cage 12, 45x22x10mm
• 08800033391364: 4CIS® Dunes PEEK DLIF Cage 12, 45x22x8mm
• 08800033391357: 4CIS® Dunes PEEK DLIF Cage 12, 45x18x20mm
• 08800033391340: 4CIS® Dunes PEEK DLIF Cage 12, 45x18x18mm
• 08800033391333: 4CIS® Dunes PEEK DLIF Cage 12, 45x18x16mm
• 08800033391326: 4CIS® Dunes PEEK DLIF Cage 12, 40x22x20mm
• 08800033391319: 4CIS® Dunes PEEK DLIF Cage 12, 40x22x18mm
• 08800033391302: 4CIS® Dunes PEEK DLIF Cage 12, 40x22x16mm
• 08800033391296: 4CIS® Dunes PEEK DLIF Cage 12, 40x22x14mm
• 08800033391289: 4CIS® Dunes PEEK DLIF Cage 12, 40x22x12mm
• 08800033391272: 4CIS® Dunes PEEK DLIF Cage 12, 40x22x10mm