ExactechGPS A00204

GUDID 10885862607171

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 Robotic surgical navigation system

Primary Device ID	10885862607171
NIH Device Record Key	0890a8ad-0ab7-44b0-abe1-e3b5f26397ba
Commercial Distribution Status	In Commercial Distribution
Brand Name	ExactechGPS
Version Model Number	Diamond Tracker2 F
Catalog Number	A00204
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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862607171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213877

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument