TRIDENT, RIO 209820

GUDID 00848486030278

STRAIGHT SHELL IMPACTOR

MAKO SURGICAL CORP.

Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor
Primary Device ID00848486030278
NIH Device Record Keydfe46f5a-ad2e-470b-bfa0-57c052014c8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIDENT, RIO
Version Model Number209820
Catalog Number209820
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
GS100848486030278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486030278]

Moist Heat or Steam Sterilization


[00848486030278]

Moist Heat or Steam Sterilization


[00848486030278]

Moist Heat or Steam Sterilization


[00848486030278]

Moist Heat or Steam Sterilization


[00848486030278]

Moist Heat or Steam Sterilization


[00848486030278]

Moist Heat or Steam Sterilization


[00848486030278]

Moist Heat or Steam Sterilization


[00848486030278]

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 [TRIDENT, RIO]

00848486030285INLINE-OFFSET SHELL IMPACTOR
00848486030278STRAIGHT SHELL IMPACTOR

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