Bio- Ultimate Platinum

GUDID 00817076010877

MICRO CURRENT TECHNOLOGY, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00817076010877
• NIH Device Record Key: 24b8baf0-b714-4802-a306-b38ea83ec489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio- Ultimate Platinum
• Version Model Number: ULTRA
• Company DUNS: 121167779
• Company Name: MICRO CURRENT TECHNOLOGY, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817076010877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181062

FDA Product Code

• NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-01-30

Devices Manufactured by MICRO CURRENT TECHNOLOGY, INC.

• 00817076014370 - myCare: 2024-08-22
• 00817076014219 - bt-sculpt: 2024-03-07
• 00817076010952 - bt-degree: 2020-05-25 IR Thermometer
• 00817076010877 - Bio- Ultimate Platinum: 2019-10-23
• 00817076010877 - Bio- Ultimate Platinum: 2019-10-23
• 00817076010884 - bt-nano: 2019-10-23
• 00817076010822 - AutoCare: 2019-10-23
• 00817076010839 - HomeCare: 2019-10-23
• 00817076010846 - CustomCare: 2019-10-23