ActivaTek Ionto4 Kit 4511

GUDID 10768627016282

ActivaTek Ionto4 Kit SM (12)

NORTH COAST MEDICAL, INC.

Multi-modality electrotherapy system

• Primary Device ID: 10768627016282
• NIH Device Record Key: b1847d15-62c1-42b1-9468-ecefcd50c85c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaTek Ionto4 Kit
• Version Model Number: NC89375
• Catalog Number: 4511
• Company DUNS: 060121928
• Company Name: NORTH COAST MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10768627016282 [Primary]
GS1	20768627016289 [Package]; Package: Master Carton [50 Units]; In Commercial Distribution

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-10
• Device Publish Date: 2025-04-02

On-Brand Devices [ActivaTek Ionto4 Kit]

• 20768627016302: ActivaTek Ionto4 Kit LG (12)
• 20768627016296: ActivaTek Ionto4 Kit MD (12)
• 10768627016282: ActivaTek Ionto4 Kit SM (12)