Disposable Reflective Marker Sphere (DRMS) 41773

GUDID 20805832010012

Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided s

Northern Digital Inc

Imaging lesion localization marker, external, single-use
Primary Device ID20805832010012
NIH Device Record Keyacd8ed20-34ee-428b-8204-15b858300c01
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Reflective Marker Sphere (DRMS)
Version Model Number41773
Catalog Number41773
Company DUNS241987692
Company NameNorthern Digital 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 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

Phone519-884-5142
Emailspheres@ndigital.com
Phone519-884-5142
Emailspheres@ndigital.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100805832010018 [Package]
Package: [30 Units]
In Commercial Distribution
GS120805832010012 [Primary]

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 Number4
Public Version Date2019-01-11
Device Publish Date2016-09-24

Devices Manufactured by Northern Digital Inc

20805832010012 - Disposable Reflective Marker Sphere (DRMS)2019-01-11Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided s
20805832010012 - Disposable Reflective Marker Sphere (DRMS)2019-01-11 Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical naviga
00805832020017 - NDI Passive Spheres2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
00805832020024 - NDI Passive Spheres2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
00805832020031 - NDI Passive Spheres2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
20805832020042 - NDI Passive Spheres2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
20805832030010 - NDI Passive Spheres2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
20805832030027 - NDI Passive Spheres2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
20805832030034 - NDI Passive Spheres2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image

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