FDA.reportPublic FDA data

NDI Passive Spheres

Primary DI
00805832040039
Brand
NDI Passive Spheres
Company
Northern Digital Inc
Model
8800739
Catalog number
8800739
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 1 sphere per inner pouch with 4 inner pouches in an outer pouch. There are 5 pouch-in-pouches for a total of 20 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
20805832040033PackageGS15In Commercial Distribution
00805832040039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2080583204003320805832040033
00805832040039008058320400398058320400390805832040039

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.

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
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
00805832020031NDI Passive Spheres880105488010542016-09-24
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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04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25