RFT M7006PE

GUDID 06938146600065

8ch Flex 70 Array

Shenzhen RF Tech Co., Ltd.

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency

• Primary Device ID: 06938146600065
• NIH Device Record Key: 31f91a30-adeb-475f-b55f-676a3f5bfd95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RFT
• Version Model Number: 10-F25061
• Catalog Number: M7006PE
• Company DUNS: 530798780
• Company Name: Shenzhen RF Tech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06938146600065 [Primary]
GS1	16938146600062 [Package]; Package: Carton Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200836

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2020-08-19
• Device Publish Date: 2020-08-11

On-Brand Devices [RFT]

• 16938146600055: 1.5T 8ch Flex 40 Array (A-port)
• 16938146600048: 1.5T 8ch Flex 50 Array (A-port)
• 16938146600031: 1.5T 8ch Flex 70 Array (A-port)
• 16938146600024: 1.5T 8ch Foot Ankle Coil
• 06938146600010: 3.0T 8ch Foot Ankle Coil
• 16938146600086: 8ch Flex 40 Array
• 16938146600079: 8ch Flex 50 Array
• 06938146600065: 8ch Flex 70 Array
• 06938146600119: The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to b
• 06938146600102: The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is d
• 16938146600130: The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed