FDA.reportPublic FDA data

NDI Passive Spheres

Primary DI
20805832040019
Brand
NDI Passive Spheres
Company
Northern Digital Inc
Model
8800737
Catalog number
8800737
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 pouch with 1 pouch in another pouch. There are 5 pouch-in-pouches for a total of 5 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
OTC
false
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
20805832040019PackageGS15In Commercial Distribution
00805832040015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2080583204001920805832040019
00805832040015008058320400158058320400150805832040015

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
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07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
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00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
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00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
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03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
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