dermaPACE System (Console with applicator)

GUDID 00812265010225

The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.

Sanuwave, Inc.

Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system

• Primary Device ID: 00812265010225
• NIH Device Record Key: 42a4ff12-ddba-4207-95d6-05cec4725be2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dermaPACE System (Console with applicator)
• Version Model Number: DEP0330/DAP0332
• 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: 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.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con
• Phone: 678-578-0108
• Email: order@sanuwave.con

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812265010225 [Primary]

FDA Product Code

• PZL: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

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

Devices Manufactured by Sanuwave, Inc.

• 00812265010201 - dermaPACE Applicator: 2021-02-02 Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers
• 00812265010218 - dermaPACE Console: 2021-02-02 Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock W
• 00812265010225 - dermaPACE System (Console with applicator): 2021-02-02The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.
• 00812265010225 - dermaPACE System (Console with applicator): 2021-02-02 The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generat
• 00812265010287 - Profile Console: 2021-02-02 Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic
• 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)
• 00812265010317 - UltraMIST Generator: 2021-02-02 The UltraMIST Generator
• 00812265010324 - UltraMIST Treatment Wand: 2021-02-02 Component to the UltraMIST System