Flex Passive Driver Kit- Large

Basic Information

• Brand Name: Flex Passive Driver Kit- Large
• Primary DI: 00850011790045
• Version / Model: REFPDL18
• Company Name: RESOUNDANT, INC.
• Labeler DUNS: 036969003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-01
• Public Version: 1
• Public Version Date: 2023-04-10
• Public Version Status: New
• Public Device Record Key: e13fb282-e773-4c9d-8219-2fea64618336

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65288	Magnetic resonance elastography acoustic driver	An assembly of devices, consisting of an electrically-powered pneumatic wave generator and a noninvasive vibration applicator, intended for use with a magnetic resonance imaging (MRI) system to provide a measure of tissue elasticity/stiffness. The generator is used outside the MRI scanner room and is connected by pneumatic tubing to the applicator, which is applied to the site of interest on the patient’s body while within the MRI scanner. The pneumatically-transferred vibrations are applied to the body and MRI images are taken to facilitate evaluation/diagnosis of the condition of tissues (e.g. liver, brain), including damage and tumours.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011790045	GS1

Premarket Submissions

Submission Number	Supplement Number
K201389	000