HTx Disposable Hysteroscope

GUDID 26974880990028

Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of the scope is 6.2 mm.

Suzhou AcuVu medical technology Co., Ltd.

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• Primary Device ID: 26974880990028
• NIH Device Record Key: 6f471e68-a03c-42f5-a058-dea46f3264d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HTx Disposable Hysteroscope
• Version Model Number: HTx60
• Company DUNS: 705464292
• Company Name: Suzhou AcuVu medical technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974880990024 [Primary]
GS1	26974880990028 [Package]; Contains: 06974880990024; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211227

FDA Product Code

• HIH: Hysteroscope (And Accessories)

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: 2022-04-11
• Device Publish Date: 2022-04-01

On-Brand Devices [HTx Disposable Hysteroscope]

• 06974880990031: Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and remove uterine
• 26974880990028: Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine
• 26974880990042: Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine