FDA.reportPublic FDA data

Hydrophilic Guidewire for Urinary Tract

Primary DI
16976055232776
Brand
Hydrophilic Guidewire for Urinary Tract
Company
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
Model
UIW-28150S
Catalog number
SF.UA11.B10
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
16976055232776PackageGS15In Commercial Distribution
26976055232773PackageGS120In Commercial Distribution
06976055232779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697605523277616976055232776
2697605523277326976055232773
06976055232779069760552327796976055232779

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
618556012
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
true
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
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
06976055232786Hydrophilic Guidewire for Urinary TractUIW-28080ASF.UA11.B112024-04-23
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

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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