Profile Applicator

GUDID 00812265010294

Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)

Sanuwave, Inc.

Dermatological extracorporeal shock wave therapy system applicator

• Primary Device ID: 00812265010294
• NIH Device Record Key: c0d43bcc-b3cd-43fc-be1c-3db053d60cb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profile Applicator
• Version Model Number: FLE0103
• Company DUNS: 832217439
• Company Name: Sanuwave, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812265010294 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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

On-Brand Devices [Profile Applicator ]

• 00812265010300: Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
• 00812265010294: Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)