Hydrophilic Guidewire for Urinary Tract SF.UA11.B21

GUDID 16976055232882

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.

SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.

Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use
Primary Device ID16976055232882
NIH Device Record Key99efe232-5f29-4f8c-bcde-b9ed1275f7ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydrophilic Guidewire for Urinary Tract
Version Model NumberUIW-38080S
Catalog NumberSF.UA11.B21
Company DUNS618556012
Company NameSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com
Phone+8675589662813
Emailinfo@hainwise.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106976055232885 [Primary]
GS116976055232882 [Package]
Contains: 06976055232885
Package: [5 Units]
In Commercial Distribution
GS126976055232889 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Product Code

OCYEndoscopic Guidewire, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-01
Device Publish Date2024-04-23

On-Brand Devices [Hydrophilic Guidewire for Urinary Tract]

16976055232684The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232912The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232905The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232899The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232882The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232875The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cla
16976055232868The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232851The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232844The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232837The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232820The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232813The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232806The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232790The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232783The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232776The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232769The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232752The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232745The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232738The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232721The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232714The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232707The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad
16976055232691The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The clad

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