Lead Surgeon Customized AR Headset with Loupes and Headlight HA0210101LO

GUDID 00850051682294

Lead Surgeon Customized AR Headset with Loupes and Headlight

OnPoint Surgical, Inc.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00850051682294
• NIH Device Record Key: bfdd44be-dda6-4407-8944-4d3bd2d69bfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lead Surgeon Customized AR Headset with Loupes and Headlight
• Version Model Number: 1
• Catalog Number: HA0210101LO
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051682294 [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

Devices Manufactured by OnPoint Surgical, Inc.

• 00850051682010 - OnPoint Surgical Cart: 2024-10-14 OnPoint Surgical Cart (with pre-installed software) - 1 headset
• 00850051682027 - OnPoint Calibration Block: 2024-10-14 Calibration phantom
• 00850051682034 - OnPoint Reusable Instrument Kit #1: 2024-10-14 OnPoint Reusable Instrument Kit #1 with 1 Fixed Adapter, 3 Rotating Adapters, and 2 Power Adapters.
• 00850051682041 - OnPoint Spine Clamp: 2024-10-14 OnPoint Spine Clamp
• 00850051682058 - OnPoint Spinal Array: 2024-10-14 OnPoint Spinal Array
• 00850051682065 - OnPoint Pelvic Pin: 2024-10-14 Pelvic Pin for MIS
• 00850051682072 - OnPoint Pelvic Pin Adapter: 2024-10-14 Pelvic Pin Adapter for Spine Array
• 00850051682089 - OnPoint Pelvic Pin Impactor Cap: 2024-10-14 Pelvic Pin Impactor Cap