Nauilus Cannulated Iliac 1385-80-5

GUDID 00190837032050

Nautilus Polyaxial Screw, 8.5mm x 80mm Cannulated

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837032050
• NIH Device Record Key: 4ec48aa3-882d-4653-bb58-a8b49043a431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nauilus Cannulated Iliac
• Version Model Number: 1385-80-5
• Catalog Number: 1385-80-5
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00190837032050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111953

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

[00190837032050]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Nauilus Cannulated Iliac]

• 00190837032074: Nautilus Polyaxial Screw, 8.5mm x 90mm Cannulated
• 00190837032067: Nautilus Polyaxial Screw, 8.5mm x 85mm Cannulated
• 00190837032050: Nautilus Polyaxial Screw, 8.5mm x 80mm Cannulated
• 00190837032043: Nautilus Polyaxial Screw, 8.5mm x 75mm Cannulated
• 00190837032036: Nautilus Polyaxial Screw, 8.5mm x 70mm Cannulated
• 00190837032029: Nautilus Polyaxial Screw, 7.5mm x 90mm Cannulated
• 00190837032012: Nautilus Polyaxial Screw, 7.5mm x 85mm Cannulated
• 00190837032005: Nautilus Polyaxial Screw, 7.5mm x 80mm Cannulated
• 00190837031992: Nautilus Polyaxial Screw, 7.5mm x 75mm Cannulated
• 00190837031985: Nautilus Polyaxial Screw, 7.5mm x 70mm Cannulated