Benesta Tissue Removal Device

GUDID 00857492008102

The Benesta Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

Caldera Medical, Inc.

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• Primary Device ID: 00857492008102
• NIH Device Record Key: 39430817-bc22-4cd5-9e24-3c1905ed4a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Benesta Tissue Removal Device
• Version Model Number: CAL-TR1511
• Company DUNS: 130341956
• Company Name: Caldera Medical, Inc.
• 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: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a clean, dry location

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857492008096 [Primary]
GS1	00857492008102 [Package]; Contains: 00857492008096; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192811

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: 2022-07-26
• Device Publish Date: 2022-07-18

Devices Manufactured by Caldera Medical, Inc.

• 00857492008003 - Transobturator Helical, Left Introducer: 2022-08-11 Transobturator Helical, 3.2mm, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion
• 00857492008010 - Transobturator Helical, Right Introducer: 2022-08-11 Transobturator Helical, 3.2mm, Right Introducer is a surgical mesh instrument to be used in surgical procedures for the insertio
• 00857492008041 - Benesta Hysteroscope Set: 2022-08-11 Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and
• 00857492008065 - Benesta Sterilization Tray: 2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len
• 00857492008133 - Benesta Sterilization Tray: 2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len
• 00890594000070 - Desara Blue SL: 2022-08-11 Desara® Blue SL sling system for female stress urinary incontinence.
• 00890594000124 - Desara Blue TVez 3.0: 2022-08-11 Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence
• 00890594000131 - Desara TVez 2.7: 2022-08-11 Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence