FDA.reportPublic FDA data

Hydrophilic Guidewire for Urinary Tract

Primary DI
06976055232786
Brand
Hydrophilic Guidewire for Urinary Tract
Company
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
Model
UIW-28080A
Catalog number
SF.UA11.B11
Device description
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
Published
2024-04-23
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

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
16976055232783PackageGS15In Commercial Distribution
26976055232780PackageGS120In Commercial Distribution
06976055232786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697605523278316976055232783
2697605523278026976055232780
06976055232786069760552327866976055232786

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+8675589662813info@hainwise.com

Regulatory Flags#

DUNS number
618556012
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976055232687Hydrophilic Guidewire for Urinary TractUIW-18080SSF.UA11.B012024-04-11
06976055232694Hydrophilic Guidewire for Urinary TractUIW-18150SSF.UA11.B022024-04-23
06976055232700Hydrophilic Guidewire for Urinary TractUIW-18080ASF.UA11.B032024-04-23
06976055232717Hydrophilic Guidewire for Urinary TractUIW-18150ASF.UA11.B042024-04-23
06976055232724Hydrophilic Guidewire for Urinary TractUIW-25080SSF.UA11.B052024-04-23
06976055232731Hydrophilic Guidewire for Urinary TractUIW-25150SSF.UA11.B062024-04-23
06976055232748Hydrophilic Guidewire for Urinary TractUIW-25080ASF.UA11.B072024-04-23
06976055232755Hydrophilic Guidewire for Urinary TractUIW-25150ASF.UA11.B082024-04-23
06976055232762Hydrophilic Guidewire for Urinary TractUIW-28080SSF.UA11.B092024-04-23
06976055232779Hydrophilic Guidewire for Urinary TractUIW-28150SSF.UA11.B102024-04-23
06976055232793Hydrophilic Guidewire for Urinary TractUIW-28150ASF.UA11.B122024-04-23
06976055232809Hydrophilic Guidewire for Urinary TractUIW-32080SSF.UA11.B132024-04-23
06976055232816Hydrophilic Guidewire for Urinary TractUIW-32150SSF.UA11.B142024-04-23
06976055232823Hydrophilic Guidewire for Urinary TractUIW-32080ASF.UA11.B152024-04-23
06976055232830Hydrophilic Guidewire for Urinary TractUIW-32150ASF.UA11.B162024-04-23
06976055232847Hydrophilic Guidewire for Urinary TractUIW-35080SSF.UA11.B172024-04-23
06976055232854Hydrophilic Guidewire for Urinary TractUIW-35150SSF.UA11.B182024-04-23
06976055232861Hydrophilic Guidewire for Urinary TractUIW-35080ASF.UA11.B192024-04-23
06976055232878Hydrophilic Guidewire for Urinary TractUIW-35150ASF.UA11.B202024-04-23
06976055232885Hydrophilic Guidewire for Urinary TractUIW-38080SSF.UA11.B212024-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06979988682185Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
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