iASSIST® 20-8011-070-19

GUDID 00889024563490

Orthosoft Inc

Orthopaedic stereotactic surgery system
Primary Device ID00889024563490
NIH Device Record Key59a2b439-ce93-4878-ad9d-4f126fcc4bb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameiASSIST®
Version Model Number20-8011-070-19
Catalog Number20-8011-070-19
Company DUNS205670032
Company NameOrthosoft Inc
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024563490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-22
Device Publish Date2020-01-14

On-Brand Devices [iASSIST® ]

0088902456349020-8011-070-19
0088902456348320-8011-070-24
0088902430550220-8011-070-01

Trademark Results [iASSIST]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IASSIST
IASSIST
97595075 not registered Live/Pending
Triangle Tube Phase III Co.
2022-09-16
IASSIST
IASSIST
90696907 not registered Live/Pending
Triangle Tube Phase III Co.
2021-05-07
IASSIST
IASSIST
86299323 not registered Dead/Abandoned
Stuart C. Irby Company
2014-06-03
IASSIST
IASSIST
85705606 4351660 Live/Registered
ZIMMER, INC.
2012-08-16
IASSIST
IASSIST
85125219 4061255 Live/Registered
AssistRX, Inc.
2010-09-08
IASSIST
IASSIST
79101806 4103905 Dead/Cancelled
SINTOKOGIO, LTD.
2011-07-19
IASSIST
IASSIST
76609005 3510344 Dead/Cancelled
Toshiba Medical Systems Corporation
2004-08-27

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