FDA.reportPublic FDA data

NDI Passive Spheres

Primary DI
00805832020031
Brand
NDI Passive Spheres
Company
Northern Digital Inc
Model
8801054
Catalog number
8801054
Device description
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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033621000NDI PASSIVE SPHERESNorthern Digital, Inc.2004-01-27HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20805832020035PackageGS112In Commercial Distribution
00805832020031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2080583202003520805832020035
00805832020031008058320200318058320200310805832020031

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, external, single-useA device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
519-884-5142spheres@ndigital.com

Regulatory Flags#

DUNS number
241987692
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20805832010012Disposable Reflective Marker Sphere (DRMS)41773417732016-09-24
00805832020048NDI Passive Spheres880100288010022016-09-24
00805832030016NDI Passive Spheres880096588009652016-09-24
00805832030023NDI Passive Spheres880096788009672016-09-24
00805832030030NDI Passive Spheres880096688009662016-09-24
00805832030047NDI Passive Spheres880132088013202016-09-24
00805832040015NDI Passive Spheres880073788007372016-09-24
00805832040022NDI Passive Spheres880073888007382016-09-24
00805832040039NDI Passive Spheres880073988007392016-09-24
00805832070012NDI Passive Sphere880107188010712016-09-24
00805832070029NDI Passive Sphere880107488010742016-09-24
00805832070036NDI Passive Sphere880107588010752016-09-24
00805832020017NDI Passive Spheres880105188010512016-09-24
00805832020024NDI Passive Spheres880105388010532016-09-24
20805832020042NDI Passive Spheres880100288010022016-09-24
20805832030010NDI Passive Spheres880096588009652016-09-24
20805832030027NDI Passive Spheres880096788009672016-09-24
20805832030034NDI Passive Spheres880096688009662016-09-24
20805832030041NDI Passive Spheres880132088013202016-09-24
20805832040019NDI Passive Spheres880073788007372016-09-24

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Primary DI, Brand, Company table
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07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
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