Lasso

GUDID 10816734023041

Lasso Polypectomy Snare

DIVERSATEK HEALTHCARE, INC.

Mechanical-cutting endoscopic polypectomy snare

• Primary Device ID: 10816734023041
• NIH Device Record Key: 97c38ad8-5aba-41fa-a51b-7306d6d02079
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lasso
• Version Model Number: 1180-14
• Company DUNS: 030650113
• Company Name: DIVERSATEK HEALTHCARE, INC.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734023044 [Primary]
GS1	10816734023041 [Package]; Contains: 00816734023044; Package: Case [10 Units]; In Commercial Distribution
GS1	20816734023048 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• FGX: Snare, Non-Electrical

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: 2021-03-08
• Device Publish Date: 2021-02-26

On-Brand Devices [Lasso]

• 10816734021610: Lasso Polypectomy Snare
• 10816734021603: Lasso Polypectomy Snare
• 10816734021597: Lasso Polypectomy Snare
• 00816734021583: Lasso Polypectomy Snare
• 10816734021573: Lasso Polypectomy Snare
• 10816734021566: Lasso Polypectomy Snare
• 10816734023058: Lasso Polypectomy Snare
• 10816734023041: Lasso Polypectomy Snare
• 10816734023034: Lasso Polypectomy Snare
• 10816734023027: Lasso Polypectomy Snare