Nautilus NC 148-123

GUDID 00190837087203

HEXALOBE DRIVER

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837087203
• NIH Device Record Key: 078e06b3-96a6-4813-987b-7e6f9e5a2c88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nautilus NC
• Version Model Number: 148-123
• Catalog Number: 148-123
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00190837087203 [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

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

Moist Heat or Steam Sterilization

[00190837087203]

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 [Nautilus NC]

• 00190837087203: HEXALOBE DRIVER
• 00190837087197: AWL, CONQUEST 2.0
• 00190837087180: 5.5mm Rod Pusher