Zebra Guidewire for Urinary Tract SF.UB11.B10

GUDID 16976055233018

The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the entire wire) with no coating on the surface and a soft tip containing a stainless steel spring; The mixed type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the part except the distal end), and a polyurethane containing tungsten (PU) cladding with hydrophilic coating on the surface (applied to the prat of distal end 60mm).

SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.

Gastro-urological guidewire, single-use
Primary Device ID16976055233018
NIH Device Record Key902345f7-276b-49da-99a2-18d2ac7ddfa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameZebra Guidewire for Urinary Tract
Version Model NumberUMW-38150A
Catalog NumberSF.UB11.B10
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
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
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
GS106976055233011 [Primary]
GS116976055233018 [Package]
Contains: 06976055233011
Package: [5 Units]
In Commercial Distribution
GS126976055233015 [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 Date2024-05-02
Device Publish Date2024-04-24

On-Brand Devices [Zebra Guidewire for Urinary Tract]

16976055233063The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055233056The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055233049The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055233032The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055233025The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055233018The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055233001The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232998The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232981The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232974The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232967The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232950The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232943The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232936The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
16976055232929The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire cons
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