Morpheus®

Basic Information

• Brand Name: Morpheus®
• Primary DI: 00852423006356
• Version / Model: RTCU
• Catalog Number: RTCU
• Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
• Labeler DUNS: 625863568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-14
• Public Version: 4
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 3f804f42-e9be-4ca8-a001-ce9133bc9d94

Device Description

10-15 MHz 360° Endoanal Ultrasound Imaging

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35712	Ultrasonic lithotripsy system	An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. This system can have a variety of configurations and will typically employ endoscopic devices together with a dedicated US transducer and probe (e.g., a sonotrode) during its application. The debris may be forcefully removed (e.g., through irrigation/suction) or passed out by natural means at a later date.	No	Active
37139	Ultrasonic lithotripsy system probe, reusable	A slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852423006356	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]