111157

GUDID 00848486002756

Fixed Driver Handle

MAKO SURGICAL CORP.

Surgical instrument handle, non-torque-limiting
Primary Device ID00848486002756
NIH Device Record Key2ee4857e-8bc1-4da5-8105-79da4034c627
Commercial Distribution StatusIn Commercial Distribution
Version Model Number111157
Catalog Number111157
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 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
GS100848486002756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486002756]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2016-09-24

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