NDI Passive Sphere 8801075

GUDID 20805832070030

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 5 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 60 spheres.

Northern Digital Inc

Imaging lesion localization marker, external, single-use
Primary Device ID20805832070030
NIH Device Record Key03ebab8b-7b1d-498f-b811-fab4f0fbf2ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameNDI Passive Sphere
Version Model Number8801075
Catalog Number8801075
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
GS100805832070036 [Primary]
GS120805832070030 [Package]
Contains: 00805832070036
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 Sphere]

00805832070043Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832070030Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832070023Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
20805832070016Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri

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