FDA.reportPublic FDA data

SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes

Primary DI
00815686021276
Brand
SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
INS-5910
Catalog number
INS-5910
Published
2021-02-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K170023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170023000SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017-05-15JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815686021273PackageGS15Not in Commercial Distribution
00815686021276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081568602127310815686021273
00815686021276008156860212768156860212760815686021276

GMDN Terms#

Term, Definition table
TermDefinition
Bronchoscopic catheterA sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815686020408vPad2 Patient TrackerINS-0050INS-00502016-08-31
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

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
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
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