dermaPACE Console

GUDID 00812265010218

Dermatological extracorporeal shock wave therapy system

Primary Device ID	00812265010218
NIH Device Record Key	c201d920-1f57-4d79-b486-a533c5cdf2de
Commercial Distribution Status	In Commercial Distribution
Brand Name	dermaPACE Console
Version Model Number	DEP0330
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

Device Issuing Agency	Device ID
GS1	00812265010218 [Primary]

PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Steralize Prior To Use	false
Device Is Sterile	false

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	2021-02-02Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.
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)	2021-02-02 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