PALS Foam

GUDID 00856817005604

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode
Primary Device ID00856817005604
NIH Device Record Keyd35acef7-17b5-4257-8f5a-9ab84d1a1b70
Commercial Distribution StatusIn Commercial Distribution
Brand NamePALS Foam
Version Model Number976230
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
GS100856817005604 [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 [PALS Foam]

00856817005628976350
00856817005611976240
00856817005604976230
00856817005598975250
00856817005581975240
00856817005574975220
00856817005567975200

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