UltraStim X Derma

GUDID 00851913006388

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode, single-use
Primary Device ID00851913006388
NIH Device Record Keyae41880f-8318-4779-86db-9504a2d3d707
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraStim X Derma
Version Model NumberUSXD2020
Company DUNS150959401
Company NameAXELGAARD MANUFACTURING CO., LTD.
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 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

Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com
Phone750-451-8000
Emailsupport@axelgaard.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851913006388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-26
Device Publish Date2024-09-18

On-Brand Devices [UltraStim X Derma]

00851913006395USXD2040
00851913006388USXD2020

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