EXACTECHGPS A10004

GUDID 10885862144263

TRACKER

Exactech, Inc.

Robotic surgical navigation system

• Primary Device ID: 10885862144263
• NIH Device Record Key: 7676b6bb-6277-4771-8f27-b5a4ff8d6424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACTECHGPS
• Version Model Number: A10004
• Catalog Number: A10004
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862144263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100742

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[10885862144263]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10885862144263]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10885862144263]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10885862144263]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10885862144263]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-03-19
• Device Publish Date: 2017-12-18

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
• 10885862635402: Glenoid Baseplate Inserter Handle
• 10885862574091: STATION2+
• 10885862553331: MOBILE CART
• 10885862518927: MOUNTING ARM
• 10885862518767: SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
• 10885862266675: TRAVEL CASE
• 10885862266668: POWER SUPPLY
• 10885862266651: IMPLANT KIT
• 10885862252821: STATION
• 10885862144294: IMPLANT KIT
• 10885862144287: TRACKER
• 10885862144270: TRACKER
• 10885862144263: TRACKER
• 10885862144256: PROBE
• 10885862144225: POWER CABLE
• 10885862144218: MOUNTING ARM CLAMP
• 10885862144195: MOUNTING ARM