Desara Blue

GUDID 00890594000674

Desara Blue sling system for female stress urinary incontinence.

CALDERA MEDICAL, INC.

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 00890594000674
• NIH Device Record Key: b2b6c828-2727-45c7-99ab-d865a3974fa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Desara Blue
• Version Model Number: CAL-DS01B
• Company DUNS: 130341956
• Company Name: CALDERA MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures

Device Identifiers

Device Issuing Agency	Device ID
GS1	00890594000650 [Package]; Package: box [5 Units]; In Commercial Distribution
GS1	00890594000667 [Package]; Package: box [1 Units]; In Commercial Distribution
GS1	00890594000674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132069

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-05-26

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