CROSSWAY

GUDID 00889095998689

Harvesting Mill, 6mm

GLOBUS MEDICAL, INC.

Manual bone mill

• Primary Device ID: 00889095998689
• NIH Device Record Key: 98eb28c5-f5fa-4e26-925a-4f4c5d23cb69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROSSWAY
• Version Model Number: 6177.2100S
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095998689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190598

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-22
• Device Publish Date: 2019-07-12

On-Brand Devices [CROSSWAY]

• 00889095998696: Adjustable Depth Stop, 18-26mm
• 00889095998689: Harvesting Mill, 6mm
• 00889095998634: Temporary Fixation Screw, 10mm
• 00889095741025: Adjustable Depth Stop, 10-18mm
• 00889095740998: Channel Guide, Right 10°
• 00889095740981: Adjustable Channel Guide
• 00889095740974: Channel Guide, Left 10°
• 00889095740929: Fixation Screw Driver
• 00889095998672: Pilot Drill, 2mm
• 00889095998658: Temporary Fixation Screw, 14mm
• 00889095998641: Temporary Fixation Screw, 12mm
• 00889095998665: Temporary Fixation Screw, 16mm