Hydrophilic Guidewire for Urinary Tract SF.UA11.B20

GUDID 16976055232875

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

• Primary Device ID: 16976055232875
• NIH Device Record Key: 16b8344e-b5a2-47eb-a5d2-882bb63e8fe6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrophilic Guidewire for Urinary Tract
• Version Model Number: UIW-35150A
• Catalog Number: SF.UA11.B20
• Company DUNS: 618556012
• Company Name: SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com
• Phone: +8675589662813
• Email: info@hainwise.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976055232878 [Primary]
GS1	16976055232875 [Package]; Contains: 06976055232878; Package: [5 Units]; In Commercial Distribution
GS1	26976055232872 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• OCY: Endoscopic Guidewire, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [Hydrophilic Guidewire for Urinary Tract]

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