FDA.reportPublic FDA data

Single Use Guidewire

Primary DI
26970401813913
Brand
Single Use Guidewire
Company
Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
Model
MD-S-GW3545
Published
2019-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
16970401813909PackageGS110In Commercial Distribution
26970401813913PackageGS15In Commercial Distribution
06970401813490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181390916970401813909
2697040181391326970401813913
06970401813490069704018134906970401813490

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16970401815095Disposable Valve SetsMD-B-AW012020-04-23
26970401814286Non-Rotatable SnaresMD-E-SNC2415242019-10-23
26970401814262Non-Rotatable SnaresMD-E-SNC2432242019-10-23
26970401814309Rotatable SnaresMD-E-SNR2415242019-10-23
26970401813739Cleaning BrushMD-A-BR-23062019-01-09
26970401813456Cleaning BrushMD-B-BR-23062018-11-23
26970401813470Cleaning BrushMD-B-BR-05102018-11-23
26970401813647Cleaning BrushMD-D-BR-05102018-12-10
26970401814248Single Use Biopsy ForcepsMD-B-BF24182019-09-25
26970401813975Single Use Biopsy ForcepsMD-C-BF24032019-06-04
26970401814002Single Use Grasping ForcepsMD-C-GF24032019-06-04
26970401813944Single Use Biopsy ForcepsMD-A-BF24182019-04-29
26970401812862Single Use HemoclipMD-L-HR-270-15-135-Y2019-03-22
26970401813890Single Use HemoclipMD-C-HR-270-13-135-Y2019-03-22
26970401813401Single Use Biopsy ForcepsMD-A-BF24162019-02-26
26970401813845Disposable Bite BlockMD-BB-CY-012019-02-26
26970401813210Rotatable SnaresMD-E-SNR2432242018-09-25
26970401813715Single Use HemoclipMD-G-HR-230-12-135-N2019-01-08
16970401813671Single Use Biopsy ForcepsMD-B-BF24232019-01-04
26970401813517Single Use Biopsy ForcepsMD-A-BF24232018-12-03

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
03600040926611ColoplastColoplast A/SOCY2024-04-19