GUDID 00195377164063

XATP MIS Penfield Blade, 80mm C-C Left

Nuvasive, Inc.

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00195377164063
• NIH Device Record Key: c816caae-995f-49e0-8cb7-045816be439f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Z200282-80
• Company DUNS: 053950783
• Company Name: Nuvasive, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00195377164063 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

Moist Heat or Steam Sterilization

[00195377164063]

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

Devices Manufactured by Nuvasive, Inc.

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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
• 00195377159847 - XLIF: 2024-05-01 XLIF Prone Anchor and Shim, Fixation Lt