Winged Guide Accessory CAL-WI

GUDID 00890594000278

The Winged Guide Accessory may be referred to as the winged guide or guide and is for use with the Caldera Medical Inside-Out introducers only.

CALDERA MEDICAL, INC.

Transobturator needle, reusable

• Primary Device ID: 00890594000278
• NIH Device Record Key: 9d302e58-cfe6-4421-84f0-2e95051629f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Winged Guide Accessory
• Version Model Number: CAL-WI
• Catalog Number: CAL-WI
• 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: false
• 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

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: 1-818-879-6555
• 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 in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry and free of contaminants supply area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00890594000278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172614

FDA Product Code

• PWJ: Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

[00890594000278]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

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