FDA.reportPublic FDA data

Single Use Urinary Guidewire

Primary DI
06936534325446
Brand
Single Use Urinary Guidewire
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-A1-UW2120
Published
2023-11-27
Public version status
Update
Distribution status
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
06936534325446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936534325446069365343254466936534325446

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA sterile 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
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
06936534300030Disposable Ureteral StentsMD-C-JC-5F-282026-09-20
06936534300054Disposable Ureteral StentsMD-C-JC-6F-282026-09-20
06936534306070Disposable Ureteral StentsMD-C-JC-4F-142026-09-20
06936534306087Disposable Ureteral StentsMD-C-JC-4.5F-142026-09-20
06936534306094Disposable Ureteral StentsMD-C-JC-4.5F-152026-09-20
06936534306100Disposable Ureteral StentsMD-C-JC-4.5F-162026-09-20
06936534306117Disposable Ureteral StentsMD-C-JC-4.5F-182026-09-20
06936534306124Disposable Ureteral StentsMD-C-JC-4.5F-202026-09-20
06936534306131Disposable Ureteral StentsMD-C-JC-4.5F-222026-09-20
06936534306148Disposable Ureteral StentsMD-C-JC-4.5F-242026-09-20
06936534306155Disposable Ureteral StentsMD-C-JC-4.5F-262026-09-20
06936534306162Disposable Ureteral StentsMD-C-JC-4.5F-282026-09-20
06936534306179Disposable Ureteral StentsMD-C-JC-4.7F-142026-09-20
06936534306186Disposable Ureteral StentsMD-C-JC-4.7F-152026-09-20
06936534306193Disposable Ureteral StentsMD-C-JC-4.7F-162026-09-20
06936534306209Disposable Ureteral StentsMD-C-JC-4.7F-182026-09-20
06936534306216Disposable Ureteral StentsMD-C-JC-4.7F-202026-09-20
06936534306223Disposable Ureteral StentsMD-C-JC-4.7F-222026-09-20
06936534306230Disposable Ureteral StentsMD-C-JC-4.7F-242026-09-20
06936534306247Disposable Ureteral StentsMD-C-JC-4.7F-262026-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421532GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
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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
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06932503510011Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510028Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
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