X-CORE

GUDID 00887517424686

X-CORE 2 Bottom Tray, Ø16mm

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: 00887517424686
• NIH Device Record Key: c43cf5d4-13cb-487f-b71c-349384c9dc1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-CORE
• Version Model Number: 7163003
• 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	00887517424686 [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

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

[00887517424686]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [X-CORE]

• 00887517526045: XCOREMINI
• 00887517526038: X-CORE VBR Ins Set
• 00887517525970: X-CORE 2 22mm Implant/Instrument Tray
• 00887517525963: X-CORE VBR Imp 22mm Set
• 00887517525901: X-CORE 2 18mm Implant/Instrument Tray
• 00887517525857: X-CORE 2 16mm Implant/Instrument Tray
• 00887517525840: X-CORE VBR Imp 18mm Set
• 00887517515957: X-CORE II Alpha 22mm Diameter Cages
• 00887517515940: X-CORE II Alpha 16 & 18mm Diameter Cages
• 00887517515933: XCOREMINI Angled Inserter Alpha
• 00887517497956: X-CORE iVBR Inserter
• 00887517497901: X-CORE iVBR Base, 7.5x18x60mm
• 00887517497895: X-CORE iVBR Base, 7.5x18x55mm
• 00887517497888: X-CORE iVBR Base, 7.5x18x50mm
• 00887517497871: X-CORE iVBR Base, 7.5x18x45mm
• 00887517497864: X-CORE iVBR Base, 7.5x18x40mm
• 00887517497857: X-CORE iVBR Wedge, 10x25mm
• 00887517497840: X-CORE iVBR Wedge, 10x20mm
• 00887517497833: X-CORE iVBR Shim, 10x25mm
• 00887517497826: X-CORE iVBR Shim, 10x20mm
• 00887517497819: X-CORE iVBR Chisel, 18mm
• 00887517497772: X-CORE iVBR Counter Torque
• 00887517497765: X-CORE iVBR Trial Reducer
• 00887517497710: X-CORE iVBR Pusher, Inserter
• 00887517490339: XLIF Corp Blade, 70mm Lung Retractor Nrw
• 00887517471734: XCORE 2 Ti Endcap, 30mm Rnd 12° Ø22
• 00887517471727: XCORE 2 Ti Endcap, 30mm Rnd 8° Ø22
• 00887517471710: XCORE 2 Ti Endcap, 30mm Rnd 4° Ø22
• 00887517471703: XCORE 2 Ti Endcap, 30mm Rnd 0° Ø22
• 00887517456847: XCORE 2 Ti Endcap, 26mm Rnd 12° Ø22
• 00887517456830: XCORE 2 Ti Endcap, 26mm Rnd 8° Ø22
• 00887517456823: XCORE 2 Ti Endcap, 26mm Rnd 4° Ø22
• 00887517456816: XCORE 2 Ti Endcap, 26mm Rnd 0° Ø22
• 00887517435873: X-CORE 2 Ti Endcap, Ø22x22x60mm 12°
• 00887517435866: X-CORE 2 Ti Endcap, Ø22x22x60mm 8°
• 00887517435859: X-CORE 2 Ti Endcap, Ø22x22x60mm 4°
• 00887517435842: X-CORE 2 Ti Endcap, Ø22x22x60mm 0°
• 00887517435460: X-CORE 2 Ti Endcap, Ø22x22x50mm 12°
• 00887517435453: X-CORE 2 Ti Endcap, Ø22x22x50mm 8°
• 00887517435446: X-CORE 2 Ti Endcap, Ø22x22x50mm 4°
• 00887517435439: X-CORE 2 Ti Endcap, Ø22x22x50mm 0°
• 00887517435422: X-CORE 2 Ti Endcap, Ø22x22x40mm 12°
• 00887517435415: X-CORE 2 Ti Endcap, Ø22x22x40mm 8°
• 00887517435408: X-CORE 2 Ti Endcap, Ø22x22x40mm 4°
• 00887517435095: X-CORE 2 Ti Endcap, Ø22x22x40mm 0°
• 00887517435019: X-CORE 2 Ti Endcap, 22mm Rnd 12° Ø22
• 00887517435002: X-CORE 2 Ti Endcap, 22mm Rnd 8° Ø22
• 00887517434692: X-CORE 2 Ti Endcap, 22mm Rnd 4° Ø22
• 00887517434685: X-CORE 2 Ti Endcap, 22mm Rnd 0° Ø22
• 00887517434609: X-CORE 2 Ti Core, Ø22x68-121mm