FDA.reportPublic FDA data

SPiN Vision Video Processor

Primary DI
00815686021320
Brand
SPiN Vision Video Processor
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
SYS-5100
Catalog number
SYS-5100
Published
2023-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815686021320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815686021320008156860213208156860213200815686021320

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic control/video-imaging systemA mains electricity (AC-powered) multifunctional device assembly designed to interface with a flexible steerable, self-propelled, or externally-propelled video endoscope (not included) to: 1) control movement of the endoscope (e.g., steer, propel); and 2) receive and process electronic video image signals sent from the endoscope. It includes a controller/control unit, image processor, and may include an image display monitor and light source. It might additionally allow control of insufflation or suction.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.EOQ2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.EOQ2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
04719872715108MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715115MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
00856571007265EasyPath RF Introducer SheathBRONCUS MEDICAL INC.EOQ2026-04-23
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00850048825086Galaxy System (Cart) - RefurbishedNoah Medical CorporationEOQ2025-10-25
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
04048551446690N/AKarl Storz GmbH & Co. KGEOQ2023-08-14
10818634025118AmbuBosma EnterprisesEOQ2023-05-01
10818634025132AmbuBosma EnterprisesEOQ2023-05-01
10818634025156AmbuBosma EnterprisesEOQ2023-05-01
10818634025163AmbuBosma EnterprisesEOQ2023-05-01