FDA.reportPublic FDA data

Jagwire

Primary DI
08714729747482
Brand
Jagwire
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00556950
Device description
High Performance Extendable Guidewire
Published
2016-09-24
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
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
08714729268789PackageGS12Not in Commercial Distribution
08714729747482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729268789087147292687898714729268789
08714729747482087147297474828714729747482

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

Regulatory Flags#

DUNS number
021717889
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
00802526629907CanGaroo®66BC05-10066BC05-1002026-05-27
00802526629914CanGaroo®66BC04-10066BC04-1002026-05-27
00802526629921CanGaroo®66BC02-10066BC02-1002026-05-27
00802526629938CanGaroo®66BC01-10066BC01-1002026-05-27
00802526629945CanGaroo®66BC03-10066BC03-1002026-05-27
00802526630002EluPro™66BE02-10066BE02-1002026-05-27
00802526630019EluPro™66BE03-10066BE03-1002026-05-27
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04953170465192VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465208VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767774SopranoColoplast A/SOCY2025-03-26
05708932767804SopranoColoplast A/SOCY2025-03-26
06932503510011Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510028Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510035Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510042Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13