Desara Blue SL

GUDID 00890594000070

Desara® Blue SL sling system for female stress urinary incontinence.

Caldera Medical, Inc.

Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer

• Primary Device ID: 00890594000070
• NIH Device Record Key: 0a377be6-0248-484f-ac1b-f0e90883cc22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Desara Blue SL
• Version Model Number: CAL-DS01BSL
• 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
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00890594000056 [Primary]
GS1	00890594000063 [Package]; Contains: 00890594000056; Package: Box [1 Units]; In Commercial Distribution
GS1	00890594000070 [Package]; Contains: 00890594000056; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121928

FDA Product Code

• OTO: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

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: 2022-08-11
• Device Publish Date: 2022-08-03

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• 00890594000070 - Desara Blue SL: 2022-08-11Desara® Blue SL sling system for female stress urinary incontinence.
• 00890594000070 - Desara Blue SL: 2022-08-11 Desara® Blue SL sling system for female stress urinary incontinence.
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• 00890594000131 - Desara TVez 2.7: 2022-08-11 Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence