MLX

GUDID 00887517492012

MLX IMPLANT TRAY, BASE

Nuvasive, Inc.

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

• Primary Device ID: 00887517492012
• NIH Device Record Key: a59f2085-bfab-484c-be70-7b194e7f272e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MLX
• Version Model Number: 1800001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517492012 [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

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

[00887517492012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [MLX]

• 00887517520869: MLX Instruments
• 00887517520852: MLX Implants
• 00887517515674: Alpha Medial Lateral Expandable Instrum
• 00887517498274: MLX Footprint Template, 42x30mm
• 00887517498267: MLX Footprint Template, 38x28mm
• 00887517498250: MLX Footprint Template, 34x24mm
• 00887517498243: MLX Tamp, Implant
• 00887517498229: MLX Multi-Tool
• 00887517498199: MLX Graft Impactor
• 00887517498144: MLX T-Handle
• 00887517498137: MLX Inserter
• 00887517498021: MLX Retrieval Tool, 38x28mm Implant
• 00887517498014: MLX Retrieval Tool, 34x24mm Implant
• 00887517362773: MLX, 12x38x28mm 8°
• 00887517362766: MLX, 12x38x28mm 4°
• 00887517362377: MLX, 10x38x28mm 8°
• 00887517362360: MLX, 10x38x28mm 4°
• 00887517361974: MLX, 8x38x28mm 8°
• 00887517361967: MLX, 8x38x28mm 4°
• 00887517361950: MLX, 8x38x28mm 0°
• 00887517361578: MLX, 12x34x24mm 8°
• 00887517361561: MLX, 12x34x24mm 4°
• 00887517361073: MLX, 10x34x24mm 8°
• 00887517361066: MLX, 10x34x24mm 4°
• 00887517360571: MLX, 8x34x24mm 8°
• 00887517360564: MLX, 8x34x24mm 4°
• 00887517343390: MLX Handle, Square
• 00887517312945: MLX Handle, Square Drive
• 00887517284808: MLX Template, 42x30mm
• 00887517284495: MLX Template, 38x28mm
• 00887517284488: MLX Template, 34x24mm
• 00887517284471: MLX Counter Torque
• 00887517282811: MLX T-Handle
• 00887517281630: MLX, 12x38x28mm 4°
• 00887517281296: MLX, 10x38x28mm 8°
• 00887517281289: MLX, 10x38x28mm 4°
• 00887517281241: MLX, 8x38x28mm 8°
• 00887517281234: MLX, 8x38x28mm 4°
• 00887517281227: MLX, 8x38x28mm 0°
• 00887517280893: MLX, 12x34x24mm 8°
• 00887517280886: MLX, 12x34x24mm 4°
• 00887517280848: MLX, 10x34x24mm 8°
• 00887517280831: MLX, 10x34x24mm 4°
• 00887517268945: MLX, 12x38x28mm 8°
• 00887517268938: MLX, 12x34x24mm 8°
• 00887517268181: MLX, 10x38x28mm 8°
• 00887517268174: MLX, 10x34x24mm 8°
• 00887517268129: MLX, 8x38x28mm 8°
• 00887517268112: MLX, 8x34x24mm 8°
• 00887517266026: MLX, 12x38x28mm 4°