FDA.reportPublic FDA data

Single Use Urinary Guidewire

Primary DI
06936534322902
Brand
Single Use Urinary Guidewire
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-A2-UW1815
Published
2023-10-25
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
06936534322902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936534322902069365343229026936534322902

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
06970401812110Single Use Grasping ForcepsMD-C-GF18062023-02-07
06970401813490Single Use GuidewireMD-S-GW35452019-03-23
06970401813766Single Use GuidewireMD-A-GW35452021-09-27
06970401815661Single Use GuidewireMD-S-GW25452020-06-17
06936534325439Single Use Urinary GuidewireMD-A1-UW21182023-11-27
06936534325446Single Use Urinary GuidewireMD-A1-UW21202023-11-27
06936534325453Single Use Urinary GuidewireMD-A1-UW21262023-11-27
06936534325460Single Use Urinary GuidewireMD-A1-UW25052023-11-27
06936534325477Single Use Urinary GuidewireMD-A1-UW25102023-11-27
06936534325484Single Use Urinary GuidewireMD-A1-UW25122023-11-27
06936534325491Single Use Urinary GuidewireMD-A1-UW25152023-11-27
06936534325507Single Use Urinary GuidewireMD-A1-UW25182023-11-27
06936534325514Single Use Urinary GuidewireMD-A1-UW25202023-11-27
06936534325521Single Use Urinary GuidewireMD-A1-UW25262023-11-27
06936534325538Single Use Urinary GuidewireMD-A1-UW28052023-11-27
06936534325545Single Use Urinary GuidewireMD-A1-UW28102023-11-27
06936534325552Single Use Urinary GuidewireMD-A1-UW28122023-11-27
06936534325569Single Use Urinary GuidewireMD-A1-UW28152023-11-27
06936534325576Single Use Urinary GuidewireMD-A1-UW28182023-11-27
06936534325583Single Use Urinary GuidewireMD-A1-UW28202023-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262494460616N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460623N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460630N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460647N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494462528N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494463969N/ADoppkon GmbH & Co. KGOCY2025-09-12
54953170465050VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465067VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465074VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465081VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465098VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465104VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465111VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465128VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465135VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465142VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465159VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465166VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465173VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465180VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465197VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465203VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767781SopranoColoplast A/SOCY2025-03-26
16932503510131Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510148Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510155Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510162Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16976055232974Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232981Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232998Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24