FDA.reportPublic FDA data

ig4 System V2, 120V, 60Hz

Primary DI
00815686020064
Brand
ig4 System V2, 120V, 60Hz
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
SYS-2000
Catalog number
SYS-2000
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

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
00815686020064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815686020064008156860200648156860200640815686020064

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation device tracking systemAn assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments typically with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/localizers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
181714804
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815686020408vPad2 Patient TrackerINS-0050INS-00502016-08-31
00815686020392vPad2 Connector CableINS-0048INS-00482016-08-31
00815686020484SPiN Vision Scope, 6.0mm OD, 3.0mm WCINS-71302023-02-11
00815686020460SPiN Vision Scope, 4.0mm OD, 2.0mm WCINS-7100INS-71002023-02-11
00815686020446Always-On Tip Tracked Guidewire, 1.0mm, 950mmINS-0305INS-03052016-08-31
00815686020477View Peripheral Catheter, 3.2mm OD, 2.0mm WCINS-0322INS-03222016-08-31
00815686020514Always-On Tip Tracked 20ga Aspiration Needle, 15mm L, 1.8mm ODINS-0342INS-03422016-08-31
00815686020538Always-On Tip Tracked Brush, 15mm L, 1.8mm ODINS-0352INS-03522016-08-31
00815686021160SPiN Access Catheter Adapter, OlympusINS-5901INS-59012020-01-30
00815686021177SPiN Access Catheter, 90 Degree CatheterINS-5911INS-59112021-02-17
00815686021184SPiN Access Catheter Always-On Tip Tracked GuidewireINS-5950INS-59502021-02-17
00815686021191"0.016"" Stylet, 1235mm L"INS-5411INS-54112020-01-30
00815686021207Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm ODINS-5300INS-53002019-10-11
00815686021269SPiN Access Catheter, 180 Degrees For Use With Olympus ScopesINS-5905INS-59052020-01-30
00815686021276SPiN Access Catheter, 90 Degrees For Use With Olympus 190 ScopesINS-5910INS-59102021-02-17
00815686021290SPiN Access Catheter, 180 Degrees For Use With Olympus 190 ScopesINS-5915INS-59152021-02-17
00815686021306SPiN Access Catheter, 90 Degrees For Use With Pentax ScopesINS-5920INS-59202021-02-17
00815686021313SPiN Access Catheter, 180 Degrees For Use With Pentax ScopesINS-5925INS-59252021-02-17
00815686021283SPiN Access Catheter, 180 Degree CatheterINS-5912INS-59122021-02-17
00815686021153SPiN Access Catheter, 90 Degree For Use With Olympus ScopesINS-5900INS-59002020-01-30

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Primary DI, Brand, Company table
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10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
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M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
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