SaeboTrodes Electrodes K3-ST-30---4

GUDID 00850331006963

SaeboTrode Electrodes, Rectangular, 2" x 3.5", 1 pack, Qty 4

SAEBO, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00850331006963
NIH Device Record Keycc5319fa-68f2-40fe-bef4-c8b0b34fcfec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaeboTrodes Electrodes
Version Model NumberK3-ST-30---4
Catalog NumberK3-ST-30---4
Company DUNS168569098
Company NameSAEBO, 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-Countertrue

Customer Support Contacts

Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.com
Phone888-284-5433
Emailinfo@saebo.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
GS100850331006963 [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 Date2016-08-14

On-Brand Devices [SaeboTrodes Electrodes ]

00850331006963SaeboTrode Electrodes, Rectangular, 2" x 3.5", 1 pack, Qty 4
00850331006956SaeboTrode Electrodes, Round, 2", 1 pack, Qty 4
00850331006949SaeboTrode Electrodes,Round 1.25", 1 pack, qty 4

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