151151

GUDID 00848486029685

Case, Leg Positioner Tray Kit

MAKO SURGICAL CORP.

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID00848486029685
NIH Device Record Key3f3bac6e-d5bf-4759-bf07-7001639aef7f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number151151
Catalog Number151151
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100848486029685 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


[00848486029685]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
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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