U.L.I.S.™

GUDID 03663136003306

MULTI-AXIAL SCREW Ø 8.5mm L 85mm

SPINEVISION

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03663136003306
• NIH Device Record Key: 85781315-68c7-43a2-96e6-fa4de450bddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U.L.I.S.™
• Version Model Number: IS2-M885T
• 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: true
• 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	03663136003306 [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

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

Moist Heat or Steam Sterilization

[03663136003306]

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: 2015-10-15

On-Brand Devices [U.L.I.S.™]

• 03663136001234: Reduction screwdriver
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• 03663136017044: Co-Cr Rigid Rod Ø6.0mm x 450mm
• 03663136003788: MOFALSEBLOC SCREW, Ø 8.5mm, L 85mm
• 03663136003702: MOFALSEBLOC SCREW, Ø 8.5mm, L 45mm
• 03663136003573: MOFALSEBLOC SCREW, Ø 6.5mm, L 40mm
• 03663136003443: MOFALSEBLOC SCREW, Ø 10.5mm, L 90mm
• 03663136003306: MULTI-AXIAL SCREW Ø 8.5mm L 85mm
• 03663136002996: MULTI-AXIAL SCREW Ø 4.5mm L 35mm
• 03663136002569: ROD PERSUADER PLIER