RIO 203866

GUDID 00848486021702

LAPTOP COMPUTER

MAKO SURGICAL CORP.

Robotic surgical navigation system
Primary Device ID00848486021702
NIH Device Record Key0fa553a9-9ba1-409b-84cb-c1a8a80cecc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIO
Version Model Number203866
Catalog Number203866
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486021702 [Primary]

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [RIO]

00848486021702LAPTOP COMPUTER
00848486020385REGISTRATION ARRAY
00848486017446BASE ARRAY
00848486017026System Irrigation Tube
00848486016319System Irrigation Clip
00848486015879RIO¿ Foot Switch
00848486002916SYSTEM QUICK CONNECT BASE ARRAY
00848486002893KNEE APPLICATION DUAL PIN ARRAY CLAMP
00848486002770KNEE APPLICATION DUAL PIN BASE CLAMP

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