LUMIS™

GUDID 03663136018782

Ø8mm CANNULATED TAP

SPINEVISION

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03663136018782
• NIH Device Record Key: c2b9d905-861f-48f0-b6c5-916386a6d61f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIS™
• Version Model Number: MS1-A118
• Company DUNS: 390377518
• Company Name: SPINEVISION
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136018782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133575

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

[03663136018782]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-12-20
• Device Publish Date: 2015-10-21

On-Brand Devices [LUMIS™]

• 03663136020181: Ti 6.0 mm x 135 mm PRE-BENT PERCUTANEOUS ROD
• 03663136018782: Ø8mm CANNULATED TAP
• 03663136007809: MULTI-AXIAL SCREW Ø 8.5mm L 60mm
• 03663136007670: MULTI-AXIAL SCREW Ø 6.5mm L 55mm
• 03663136006949: MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 45mm
• 03663136006925: MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 35mm