ExactechGPS A00206

GUDID 10885862607195

Exactech, Inc.

Robotic surgical navigation system

• Primary Device ID: 10885862607195
• NIH Device Record Key: c7e78639-70eb-45f3-9e7c-86d086f363fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExactechGPS
• Version Model Number: Diamond Tracker2 G
• Catalog Number: A00206
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862607195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213877

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[10885862607195]

Moist Heat or Steam Sterilization

[10885862607195]

Moist Heat or Steam Sterilization

[10885862607195]

Moist Heat or Steam Sterilization

[10885862607195]

Moist Heat or Steam Sterilization

[10885862607195]

Moist Heat or Steam Sterilization

[10885862607195]

Moist Heat or Steam Sterilization

[10885862607195]

Moist Heat or Steam Sterilization

[10885862607195]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-29
• Device Publish Date: 2022-06-21

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