UltraMIST Treatment Wand

GUDID 00812265010324

Component to the UltraMIST System

Sanuwave, Inc.

Wound therapy ultrasound system
Primary Device ID00812265010324
NIH Device Record Keycbd2aacb-df3a-4581-86e9-e8d7d0c3b48d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraMIST Treatment Wand
Version Model NumberCP-80033
Company DUNS832217439
Company NameSanuwave, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com
Phone678-578-0108
Emailorder@sanuwave.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812265010324 [Primary]
GS100816789010204 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRBWound Cleaner, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-02
Device Publish Date2021-01-25

Devices Manufactured by Sanuwave, Inc.

00812265010201 - dermaPACE Applicator2021-02-02 Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers
00812265010218 - dermaPACE Console2021-02-02 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 Console2021-02-02 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 Generator2021-02-02 The UltraMIST Generator
00812265010324 - UltraMIST Treatment Wand2021-02-02Component to the UltraMIST System
00812265010324 - UltraMIST Treatment Wand2021-02-02 Component to the UltraMIST System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.