Magnetic cup

GUDID 06971355420826

SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 06971355420826
• NIH Device Record Key: d19a3b44-4b17-4ea9-a171-b9ec76776279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magnetic cup
• Version Model Number: MAG01
• Company DUNS: 543063066
• Company Name: SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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	06971355420826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210154

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2022-02-04
• Device Publish Date: 2022-01-27

On-Brand Devices [Magnetic cup]

• 06971355420833: MAG02
• 06971355420826: MAG01