StruXure

GUDID 00887517524980

StruXure Instrument Tray 2

Nuvasive, Inc.

Sterilization/disinfection container 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: 00887517524980
• NIH Device Record Key: d78f1010-0ad0-4e1b-b348-927a8753d57e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StruXure
• Version Model Number: STRUXINS2
• 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
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517524980 [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

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

[00887517524980]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2016-09-23

On-Brand Devices [StruXure]

• 00887517524997: StruXure Long Construct Tray
• 00887517524980: StruXure Instrument Tray 2
• 00887517524973: StruXure Instrument Tray 1
• 00887517524966: StruXure Implant Core Tray
• 00887517504067: StruXure Dilator, Grooved
• 00887517412447: StruXure Screw, 9.5x60mm Mid Body
• 00887517412430: StruXure Screw, 9.5x55mm Mid Body
• 00887517412423: StruXure Screw, 9.5x50mm Mid Body
• 00887517412416: StruXure Screw, 9.5x45mm Mid Body
• 00887517412409: StruXure Screw, 9.5x40mm Mid Body
• 00887517412195: StruXure Screw, 9.5x35mm Mid Body
• 00887517412188: StruXure Screw, 9.5x30mm Mid Body
• 00887517412171: StruXure Screw, 9.5x25mm Mid Body
• 00887517412157: StruXure Screw, 8.5x60mm Mid Body
• 00887517412140: StruXure Screw, 8.5x55mm Mid Body
• 00887517412133: StruXure Screw, 8.5x50mm Mid Body
• 00887517412126: StruXure Screw, 8.5x45mm Mid Body
• 00887517412119: StruXure Screw, 8.5x40mm Mid Body
• 00887517412102: StruXure Screw, 8.5x35mm Mid Body
• 00887517411693: StruXure Screw, 8.5x30mm Mid Body
• 00887517411686: StruXure Screw, 8.5x25mm Mid Body
• 00887517411662: StruXure Screw, 6.5x60mm
• 00887517411655: StruXure Screw, 6.5x55mm
• 00887517411648: StruXure Screw, 6.5x50mm
• 00887517411631: StruXure Screw, 6.5x45mm
• 00887517411624: StruXure Screw, 6.5x40mm
• 00887517411617: StruXure Screw, 6.5x35mm
• 00887517411600: StruXure Screw, 6.5x30mm
• 00887517411396: StruXure Screw, 6.5x25mm
• 00887517411372: StruXure Screw, 5.5x60mm
• 00887517411365: StruXure Screw, 5.5x55mm
• 00887517411358: StruXure Screw, 5.5x50mm
• 00887517411341: StruXure Screw, 5.5x45mm
• 00887517411334: StruXure Screw, 5.5x40mm
• 00887517411327: StruXure Screw, 5.5x35mm
• 00887517411310: StruXure Screw, 5.5x30mm
• 00887517411303: StruXure Screw, 5.5x25mm
• 00887517410993: StruXure Bolt, 10.5x40mm Mid Body
• 00887517410986: StruXure Bolt, 10.5x30mm Mid Body
• 00887517410542: StruXure Bolt, 10.5x60mm Mid Body
• 00887517410535: StruXure Bolt, 10.5x55mm Mid Body
• 00887517410528: StruXure Bolt, 10.5x50mm Mid Body
• 00887517410511: StruXure Bolt, 10.5x45mm Mid Body
• 00887517410191: StruXure Bolt, 10.5x35mm Mid Body
• 00887517410177: StruXure Bolt, 10.5x25mm Mid Body
• 00887517409744: StruXure Rod, 5.5x300mm
• 00887517409089: StruXure Rod, 5.5x200mm
• 00887517408877: StruXure Template, Staple Insert
• 00887517408433: StruXure Rod Holder, 5.5mm
• 00887517408402: StruXure Counter Torque