FDA.reportPublic FDA data

vPad2 Patient Tracker

Primary DI
00815686020408
Brand
vPad2 Patient Tracker
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
INS-0050
Catalog number
INS-0050
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122106000SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLEVeran Medical Technologies, Inc.2012-12-21JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815686020405PackageGS15Not in Commercial Distribution
00815686020408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081568602040510815686020405
00815686020408008156860204088156860204080815686020408

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical tracking system spatial marker, external, non-poweredA non-powered, noninvasive component of an electromagnetic surgical tracking system intended to provide a reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure; the EM-tracking diagrams may be subsequently overlaid on radiological images for surgical navigation. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an electrically-powered marker for active registration. This is a single-use device.

Regulatory Flags#

DUNS number
181714804
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
true
Expiration date on label
false
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
00815686020439Always-On Trip Tracked Guidewire, 1.0mm, 735mmINS-0304INS-03042016-08-31
00815686020446Always-On Tip Tracked Guidewire, 1.0mm, 950mmINS-0305INS-03052016-08-31
00815686020064ig4 System V2, 120V, 60HzSYS-2000SYS-20002016-08-31
00815686020071ig4 System V2, 230V, 50HzSYS-2230SYS-22302016-08-31
00815686020088ig4 System, 120V, 60HzSYS-3000SYS-30002016-08-31
00815686020095ig4 System, 230V, 50HzSYS-3230SYS-32302016-08-31
00815686020101SPiN Thoracic Navigation System, 120V, 60HzSYS-4000SYS-40002016-11-16
00815686020118SPiN Thoracic Navigation System, 230V, 50HzSYS-4230SYS-42302016-11-16
0081568602023117ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5022INS-50222016-08-31
0081568602024817ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5023INS-50232016-08-31
0081568602025517ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5024INS-50242016-08-31
0081568602026218ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5025INS-50252016-08-31
0081568602027918ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5026INS-50262016-08-31
0081568602028618ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5027INS-50272016-08-31
0081568602029319 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5028INS-50282016-08-31
0081568602030919 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5029INS-50292016-08-31
0081568602031619 UTW, 45mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5030INS-50302016-08-31
0081568602032319 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5031INS-50312016-08-31
0081568602033019 UTW, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5032INS-50322016-08-31
0081568602034719 UTW, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5033INS-50332016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
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00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
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00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29