160336

GUDID 00848486003166

HIP PROBE

MAKO SURGICAL CORP.

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Primary Device ID	00848486003166
NIH Device Record Key	8baac26f-1c64-4e18-93af-ed388c9948a9
Commercial Distribution Status	In Commercial Distribution
Version Model Number	160336
Catalog Number	160336
Company DUNS	175239677
Company Name	MAKO SURGICAL CORP.
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	00848486003166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121064

FDA Product Code

OLO	Orthopedic stereotaxic instrument