XLX

GUDID 00887517954503

Alpha XLX ACR Instrument Tray 2

Nuvasive, Inc.

Sterilization/disinfection container 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: 00887517954503
• NIH Device Record Key: 56e86e62-352b-4300-aa75-12512b664fa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLX
• Version Model Number: ALPXLXACRINS2
• 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
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517954503 [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

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

[00887517954503]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-10
• Device Publish Date: 2018-07-02

On-Brand Devices [XLX]

• 00887517944900: XLX ACR Set Screw, Plate
• 00887517943897: XLX ACR Plug, Graft Containment
• 00887517945204: XLX ACR Inserter, Low Profile
• 00887517944986: XLX ACR Inserter, Standard
• 00887517944962: XLX ACR Expansion Driver, Std Inserter
• 00887517944955: XLX ACR Drive Shaft, Standard Inserter
• 00887517944948: XLX ACR Inserter Adapter, Unplated
• 00887517944931: XLX ACR Shaft, Main Unplted Std Inserter
• 00887517944924: XLX ACR Shaft, Main Plated Std Inserter
• 00887517944856: XLX ACR Shaft, Unplated LP Inserter
• 00887517944849: XLX ACR Shaft, Plated LP Inserter
• 00887517968616: XLX ACR T-Handle, Torque Limiting
• 00887517960313: XLX ACR Plate, 18.0mm
• 00887517960306: XLX ACR Plate, 17.0mm
• 00887517960290: XLX ACR Plate, 16.0mm
• 00887517960283: XLX ACR Plate, 15.0mm
• 00887517960276: XLX ACR Plate, 14.0mm
• 00887517960269: XLX ACR Plate, 12.0mm
• 00887517960252: XLX ACR Plate, 12.0mm
• 00887517960245: XLX ACR Plate, 11.0mm
• 00887517954961: XLX ACR Trial, 12mm 30°
• 00887517954954: XLX ACR Trial, 10mm 30°
• 00887517954947: XLX ACR Trial, 8mm 30°
• 00887517954930: XLX ACR Trial, 6mm 30°
• 00887517954923: XLX ACR Trial, 4mm 30°
• 00887517954916: XLX ACR Trial, 12mm 20°
• 00887517954909: XLX ACR Trial, 10mm 20°
• 00887517954503: Alpha XLX ACR Instrument Tray 2
• 00887517953698: Alpha XLX ACR Instrument Tray 1
• 00887517953681: Alpha XLX ACR Implant Tray
• 00887517947994: XLX ACR Trial, 8mm 20°
• 00887517947987: XLX ACR Trial, 6mm 20°
• 00887517947970: XLX ACR Trial, 4mm 20°
• 00887517947451: XLX ACR Loading Block
• 00887517947437: XLX ACR Counter Torque
• 00887517945228: XLX ACR Distractor, Parallel
• 00887517945211: XLX ACR Awl
• 00887517945174: XLX ACR Blade Clip, Posterior
• 00887517945167: XLX ACR Driver, Screw Final
• 00887517945136: XLX ACR Cutter, Ant Longitud Ligament W
• 00887517945129: XLX ACR Driver, Expansion Stand Alone
• 00887517945112: XLX ACR Driver, Long S.S./Graft Plug
• 00887517945105: XLX ACR Driver, Short S.S./Graft Plug
• 00887517945099: XLX ACR Trial, 12mm 10°
• 00887517945082: XLX ACR Trial, 10mm 10°
• 00887517945075: XLX ACR Trial, 8mm 10°
• 00887517945068: XLX ACR Trial, 6mm 10°
• 00887517945051: XLX ACR Trial, 4mm 10°
• 00887517945044: XLX ACR Cutter, Ant LongitudLigament Nrw
• 00887517945037: XLX ACR Funnel, Graft