111695

GUDID 00848486016326

IRRIGATION TUBE

MAKO SURGICAL CORP.

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Primary Device ID00848486016326
NIH Device Record Key55f49782-dd96-4964-a27d-cd875bc456b1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number111695
Catalog Number111695
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486016326 [Primary]

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-09-24

Devices Manufactured by MAKO SURGICAL CORP.

07613327599985 - Mako2023-07-31
07613327600001 - Mako2023-07-31
07613327600063 - Mako2023-07-31
07613327600070 - Mako2023-07-31
07613327601008 - Mako2023-07-31
00848486022747 - Calibration End Effector Inverted2022-10-13 Calibration End Effector Inverted
07613327395341 - Mako2021-04-07
07613327395280 - NA2020-12-23

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