Flex Passive Driver Kit- Large

GUDID 00850011790045

RESOUNDANT, INC.

Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver Magnetic resonance elastography acoustic driver

• Primary Device ID: 00850011790045
• NIH Device Record Key: e13fb282-e773-4c9d-8219-2fea64618336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex Passive Driver Kit- Large
• Version Model Number: REFPDL18
• Company DUNS: 036969003
• Company Name: RESOUNDANT, INC.
• 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: true
• 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	00850011790045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201389

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2023-04-10
• Device Publish Date: 2023-04-01

Devices Manufactured by RESOUNDANT, INC.

• 00850011790045 - Flex Passive Driver Kit- Large: 2023-04-10
• 00850011790045 - Flex Passive Driver Kit- Large: 2023-04-10
• 00850011790052 - Flex Passive Driver Kit- Small: 2023-04-10
• 00850011790106 - Passive Driver: 2023-03-01
• 00850011790199 - Hepatogram Plus: 2022-04-21
• 00850011790007 - MREplus: 2021-04-09
• 00850011790014 - MREplus: 2021-04-09