NDI Passive Spheres 8801054

GUDID 00805832020031

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres.

Northern Digital Inc

Imaging lesion localization marker, external, single-use
Primary Device ID00805832020031
NIH Device Record Key538b1aee-8f68-4c07-90e8-a512e2ee7b6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNDI Passive Spheres
Version Model Number8801054
Catalog Number8801054
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
GS100805832020031 [Primary]
GS120805832020035 [Package]
Package: Tray in Pouch [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [NDI Passive Spheres]

20805832040033Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832040026Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832040019Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832030041Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832030034Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832030027Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832030010Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832020042Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
00805832020031Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
00805832020024Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
00805832020017Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri

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