UltraMIST Treatment Wand

GUDID 00812265010324

Component to the UltraMIST System

Sanuwave, Inc.

Wound therapy ultrasound system

• Primary Device ID: 00812265010324
• NIH Device Record Key: cbd2aacb-df3a-4581-86e9-e8d7d0c3b48d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraMIST Treatment Wand
• Version Model Number: CP-80033
• Company DUNS: 832217439
• Company Name: Sanuwave, 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com
• Phone: 678-578-0108
• Email: order@sanuwave.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812265010324 [Primary]
GS1	00816789010204 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140782

FDA Product Code

• NRB: Wound Cleaner, Ultrasound

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-02
• Device Publish Date: 2021-01-25

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• 00812265010294 - Profile Applicator: 2021-02-02 Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
• 00812265010300 - Profile Applicator: 2021-02-02 Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
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• 00812265010324 - UltraMIST Treatment Wand: 2021-02-02 Component to the UltraMIST System