NavitrackER 20-8000-000-07

GUDID 00889024304222

Orthosoft Inc

Imaging lesion localization marker, external, single-use
Primary Device ID00889024304222
NIH Device Record Key6ac582cb-b589-4c27-b44c-dbc5f2894c22
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavitrackER
Version Model Number20-8000-000-07
Catalog Number20-8000-000-07
Company DUNS205670032
Company NameOrthosoft Inc
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
GS100889024304222 [Primary]
GS100889024466333 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

On-Brand Devices [NavitrackER]

0088902430501420-8000-070-05
0088902430423920-8000-000-08
0088902430422220-8000-000-07

Trademark Results [NavitrackER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NAVITRACKER
NAVITRACKER
77089292 3550745 Live/Registered
ORTHOSOFT ULC
2007-01-23
NAVITRACKER
NAVITRACKER
74669249 not registered Dead/Abandoned
NAVITRAK INTERNATIONAL CORPORATION
1995-05-03

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