TLX

GUDID 00195377000644

Launch TLX 20° Low-profile Instruments

Nuvasive, Inc.

Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00195377000644
• NIH Device Record Key: 1776650d-cfa7-45f2-8c13-6710d248da58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLX
• Version Model Number: TLX20LPINS2
• 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
• 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	00195377000644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143579

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

[00195377000644]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-05

On-Brand Devices [TLX]

• 00887517988102: TLX20 Counter Torque, Low Profile
• 00887517987013: TLX20 Inserter, Low Profile
• 00887517987006: TLX20 Strike Plate, Low Profile
• 00887517826169: TLX Inserter, w/ Graft Delivery 20°
• 00887517729415: TLX Inserter, Quick Connect
• 00887517991461: TLX 20° LP Inserter Instruments
• 00887517730633: TLX Implant, 9x13x40mm 12°
• 00887517730626: TLX Implant, 9x13x36mm 15°
• 00887517730619: TLX Implant, 9x13x31mm 15°
• 00887517730602: TLX Implant, 9x13x27mm 15°
• 00887517730596: TLX Implant, 9x13x26mm 15°
• 00887517730589: TLX Implant, 9x11x40mm 12°
• 00887517730558: TLX Implant, 9x11x27mm 15°
• 00887517730480: TLX Implant, 8x13x40mm 10°
• 00887517730473: TLX Implant, 8x13x36mm 12°
• 00887517730466: TLX Implant, 8x13x31mm 15°
• 00887517730459: TLX Implant, 8x13x27mm 15°
• 00887517730442: TLX Implant, 8x13x26mm 15°
• 00887517730435: TLX Implant, 8x11x40mm 10°
• 00887517730404: TLX Implant, 8x11x27mm 15°
• 00887517730381: TLX Implant, 7x13x40mm 10°
• 00887517730374: TLX Implant, 7x13x36mm 12°
• 00887517730367: TLX Implant, 7x13x31mm 15°
• 00887517730350: TLX Implant, 7x13x27mm 15°
• 00887517730343: TLX Implant, 7x13x26mm 15°
• 00887517730336: TLX Implant, 7x11x40mm 9°
• 00887517958587: TLX20, 16x11x36mm 15°
• 00887517958570: TLX20, 15x11x36mm 15°
• 00887517958556: TLX20, 13x11x36mm 15°
• 00887517958518: TLX20, 9x11x41mm 13°
• 00887517958488: TLX20, 16x11x41mm 13°
• 00887517958471: TLX20, 15x11x41mm 13°
• 00887517958464: TLX20, 14x11x41mm 13°
• 00887517958457: TLX20, 13x11x41mm 13°
• 00887517958440: TLX20, 12x11x41mm 13°
• 00887517958433: TLX20, 11x11x41mm 13°
• 00887517958426: TLX20, 10x11x41mm 13°
• 00887517958402: TLX20, 9x11x27mm 20°
• 00887517958372: TLX20, 8x11x27mm 20°
• 00887517958341: TLX20, 7x11x27mm 20°
• 00887517958327: TLX20, 16x11x31mm 20°
• 00887517958310: TLX20, 16x11x27mm 20°
• 00887517958303: TLX20, 16x11x26mm 20°
• 00887517958297: TLX20, 15x11x31mm 20°
• 00887517958280: TLX20, 15x11x27mm 20°
• 00887517958273: TLX20, 15x11x26mm 20°
• 00887517958259: TLX20, 14x11x27mm 20°
• 00887517958235: TLX20, 13x11x31mm 20°
• 00887517958228: TLX20, 13x11x27mm 20°
• 00887517958211: TLX20, 13x11x26mm 20°