FDA.reportPublic FDA data

VISIGLIDE2

Primary DI
04953170465192
Brand
VISIGLIDE2
Company
TERUMO CORPORATION
Model
G-260-3527S
Catalog number
N5367831
Device description
VISIGLIDE2 Single Use Guidewire
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCYEndoscopic guidewire, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54953170465197PackageGS15In Commercial Distribution
04953170465192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5495317046519754953170465197
04953170465192049531704651924953170465192

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length2700Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight. Stacking limit by 8.

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
690543319
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350722089Misago®SXR06060LSX*FXA0660LN2015-05-30
04987350722102Misago®SXR06080LSX*FXA0680LN2015-05-30
04987350722126Misago®SXR06120LSX*FXA06X2LN2015-05-30
04987350722140Misago®SXR06150LSX*FXA06X5LN2015-05-30
04987350722164Misago®SXR07040LSX*FXA0740LN2015-05-30
04987350722188Misago®SXR07060LSX*FXA0760LN2015-05-30
04987350722201Misago®SXR07080LSX*FXA0780LN2015-05-30
04987350722225Misago®SXR07100LSX*FXA07X0LN2015-05-30
04987350722287Misago®SXR08040LSX*FXA0840LN2015-05-30
04987350722300Misago®SXR08060LSX*FXA0860LN2015-05-30
04987350722324Misago®SXR08080LSX*FXA0880LN2015-05-30
04987350722348Misago®SXR08100LSX*FXA08X0LN2015-05-30
04987350722362Misago®SXR06100LSX*FXA06X0LN2015-05-30
04987350722065Misago®SXR06040LSX*FXA0640LN2015-05-30
04987350722249Misago®SXR07120LSX*FXA07X2LN2015-05-30
04987350722263Misago®SXR07150LSX*FXA07X5LN2015-05-30
04987350739124CAPIOXCX*FX05WACX*FX05WA2021-07-06
04987350739100CAPIOXCX*FX05EACX*FX05EA2021-07-01
04987350781710CAPIOX®FXCX*FX05E2015-09-15
04987350781734CAPIOX®FXCX*FX05W2015-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979988682154Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
06979988682161Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
06979988682178Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
06979988682185Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
08809909421532GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421549GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421556GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421563GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421570GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421587GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421594GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421600GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
04953170465055VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465062VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465079VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465086VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465093VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465109VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465116VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465123VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465130VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465147VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465154VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465161VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465178VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465185VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465208VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767774SopranoColoplast A/SOCY2025-03-26
05708932767804SopranoColoplast A/SOCY2025-03-26
03600040926611ColoplastColoplast A/SOCY2024-04-19