UltraStim Wire

GUDID 00856817005758

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode
Primary Device ID00856817005758
NIH Device Record Keya2d7f294-9396-43ce-a828-42e391026e02
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraStim Wire
Version Model NumberUF2750
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 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-Countertrue

Customer Support Contacts

Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
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
GS100856817005758 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-31

On-Brand Devices [UltraStim Wire]

00856817005796UF2400
00856817005789UF1525
00856817005772UF2040
00856817005765UF2020
00856817005758UF2750
00856817005741UF2000
00856817005734UF1250

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