SaeboTrodes Electrodes K3-ST-20---4

GUDID 00850331006956

SaeboTrode Electrodes, Round, 2", 1 pack, Qty 4

SAEBO, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00850331006956
• NIH Device Record Key: 1cb8a4a8-68bb-4154-a55c-a647658bebc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SaeboTrodes Electrodes
• Version Model Number: K3-ST-20---4
• Catalog Number: K3-ST-20---4
• Company DUNS: 168569098
• Company Name: SAEBO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com
• Phone: 888-284-5433
• Email: info@saebo.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850331006956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-14

On-Brand Devices [SaeboTrodes Electrodes ]

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