UltraMIST Single Use Applicator

GUDID 00812265010331

Applicator fr UltraMIST (Wound Cleanser)

Sanuwave, Inc.

Wound therapy ultrasound system
Primary Device ID00812265010331
NIH Device Record Key5dfcdd98-9702-4767-975d-897bbe4e0fb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraMIST Single Use Applicator
Version Model NumberAS-55057
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812265010331 [Primary]
GS100816789010235 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRBWound Cleaner, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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.

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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 Wand2021-02-02 Component to the UltraMIST System

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