EXACTECHGPS I00032

GUDID 10885862628961

Station V3 Carrying Case

Exactech, Inc.

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system

• Primary Device ID: 10885862628961
• NIH Device Record Key: 682f8cd4-95b6-4c52-a679-c716d8efb196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACTECHGPS
• Version Model Number: I00032
• Catalog Number: I00032
• Company DUNS: 157565946
• Company Name: Exactech, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862628961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233299

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

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: 2024-04-15
• Device Publish Date: 2024-04-05

On-Brand Devices [EXACTECHGPS]

• 10885862607195: Diamond Tracker2 G
• 10885862607188: Diamond Tracker2 T
• 10885862607171: Diamond Tracker2 F
• 10885862607164: Probe Tracker2 P
• 10885862625601: Mounting Arm – Upper Part 4 positions
• 10885862632715: Station V3 Disposable Kit
• 10885862628961: Station V3 Carrying Case
• 10885862628954: Station V3 Power Supply
• 10885862628947: Station V3