XKnife®

GUDID M433XKNIFETK1

XKnife Tool Kit

INTEGRA LIFESCIENCES CORPORATION

Stereotactic radiosurgical invasive head frame

• Primary Device ID: M433XKNIFETK1
• NIH Device Record Key: 8373ca4f-013b-4ed9-8042-798c8cc5179a
• Commercial Distribution Discontinuation: 2023-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: XKnife®
• Version Model Number: XKNIFETK
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• 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(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780252962 [Primary]
HIBCC	M433XKNIFETK1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100417

FDA Product Code

• MUJ: System,planning,radiation therapy treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-03-19
• Device Publish Date: 2016-07-26

On-Brand Devices [XKnife®]

• M433XKNIFETK1: XKnife Tool Kit
• M433XK503UPK1: XKnife 5.0.3 Upgrade Kit
• M433XK51: XKnife 5.0 Installation Kit
• M433RTLXCOMP1: XKnife Linux RT Workstation