RESTORIS, PST, RIO 209420

GUDID 00848486023010

INLINE-OFFSET SHELL IMPACTOR

MAKO SURGICAL CORP.

Orthopaedic implant impactor
Primary Device ID00848486023010
NIH Device Record Key9343d8fc-f4f1-439d-9d21-2af407070329
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESTORIS, PST, RIO
Version Model Number209420
Catalog Number209420
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
GS100848486023010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486023010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [RESTORIS, PST, RIO]

00848486030049Shell Impactor, Offset
00848486023010INLINE-OFFSET SHELL IMPACTOR
00848486022983Offset Shell Impactor
00848486022907SHELL IMPACTOR, STRAIGHT

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