GUDID 00195377162175

MOD-EX PL Inserter, Hex

Nuvasive, Inc.

Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00195377162175
• NIH Device Record Key: e1bdf640-756a-4148-af45-2bc0206ae5d0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Z500162
• Company DUNS: 053950783
• Company Name: Nuvasive, 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

Customer Support Contacts

• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195377162175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210214

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

[00195377162175]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-15
• Device Publish Date: 2024-01-05

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• 00195377055538 - Nimbus: 2024-05-01 Nimbus Adapter, Large Clamp
• 00195377055545 - Nimbus: 2024-05-01 Nimbus Adapter, Medium Clamp
• 00195377055552 - Nimbus: 2024-05-01 Nimbus Adapter, Small Clamp
• 00195377061232 - Nimbus: 2024-05-01 Nimbus Adapters Tray
• 00195377159847 - XLIF: 2024-05-01 XLIF Prone Anchor and Shim, Fixation Lt