Single-use Extraction Baskets

GUDID 16971381252757

The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Urinary stone retrieval basket, single-use

• Primary Device ID: 16971381252757
• NIH Device Record Key: 70b23771-1298-4ade-b113-5e671b7e927c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Extraction Baskets
• Version Model Number: EBF-1511S
• Company DUNS: 544519831
• Company Name: SCIVITA 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971381252750 [Primary]
GS1	16971381252757 [Package]; Contains: 06971381252750; Package: [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240192

FDA Product Code

• LQR: Dislodger, Stone, Biliary

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: 2024-12-16
• Device Publish Date: 2024-12-06

On-Brand Devices [Single-use Extraction Baskets]

• 16971381251675: The single-use extraction baskets is used in combination with the endoscope, entering from the u
• 16971381251668: The single-use extraction baskets is used in combination with the endoscope, entering from the u
• 16971381251651: The single-use extraction baskets is used in combination with the endoscope, entering from the u
• 06971381251647: The single-use extraction baskets is used in combination with the endoscope, entering from the u
• 16971381252955: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252948: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252931: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252924: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252917: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252900: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252832: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252825: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252818: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252801: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252795: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252788: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252771: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252764: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252757: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252740: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 16971381252733: The product is composed of basket assembly, sheath assembly and handle assembly. This product is
• 06971381252729: The product is composed of basket assembly, sheath assembly and handle assembly. This product is