OnPoint Surgical Cart NK0210101

GUDID 00850051682010

OnPoint Surgical Cart (with pre-installed software) - 1 headset

OnPoint Surgical, Inc.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00850051682010
• NIH Device Record Key: b54cb8bc-e0a5-480b-b5d5-a2ce38533395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnPoint Surgical Cart
• Version Model Number: 1
• Catalog Number: NK0210101
• Company DUNS: 080659059
• Company Name: OnPoint Surgical, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com
• Phone: 888-241-2709
• Email: support@onpointsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051682010 [Primary]

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [OnPoint Surgical Cart]

• 00850051682485: OnPoint Surgical Cart (with pre-installed software) - 2 headsets
• 00850051682386: OnPoint Surgical Cart (with pre-installed software) - 3 headsets
• 00850051682010: OnPoint Surgical Cart (with pre-installed software) - 1 headset