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

• 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