GUDID 00195377163615

MOD-EX PL Inserter, Locking Thumbwheel

Nuvasive, Inc.

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00195377163615
• NIH Device Record Key: f10cd992-c05a-473a-bc27-063b24f4d0e8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Z500166
• 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	00195377163615 [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

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

Moist Heat or Steam Sterilization

[00195377163615]

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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• 00195377161314 - ReLine: 2024-05-29 RELINE Lock Screw Starter, Politician
• 00195377055521 - Nimbus: 2024-05-01 Maxcess Adapter, A-Arm Threaded
• 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