RE3

GUDID 08600105136202

RE3 robotic excoscope system and accessories.

Digital Surgery Systems, Inc.

Neurosurgical microscope

• Primary Device ID: 08600105136202
• NIH Device Record Key: 60d45fed-9cbd-4d27-a01a-3463c5de43f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RE3
• Version Model Number: 5900-0208
• Company DUNS: 095204175
• Company Name: Digital Surgery Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	08600105136202 [Primary]

FDA Product Code

• FSO: Microscope, Surgical, General & Plastic Surgery

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: 2025-07-23
• Device Publish Date: 2025-07-15