FDA.reportPublic FDA data

Morpheus®

Primary DI
00852423006462
Brand
Morpheus®
Company
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
Model
RTTU
Catalog number
RTTU
Device description
Morpheus® Transperineal Ultrasound Imaging
Published
2021-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852423006462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852423006462008524230064628524230064620852423006462

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic lithotripsy system reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-442-2325info@theprogrp.com

Regulatory Flags#

DUNS number
625863568
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852423006035PathwayPDUOPDUO2016-09-26
00852423006301N/AULCWLC2016-09-26
00852423006387WiFLOWWI-LCWLC2017-02-14
00852423006479EMYO® EMYO® 200SEM200S2021-08-31
00852423006486EMYO®EMYO® 100SEM100S2021-08-31
00852423006448EMYO®EMYO®200EM2002020-06-23
00852423006455EMYO®EMYO®100EM100-N2020-06-23
00852423006431TELESIS®9250-ST9250-ST2019-10-03
00852423006004MorpheusMOR0118MOR01182016-09-26
00852423006011PathwayCTS2000CTS20002016-09-26
00852423006028PathwayCTS1500CTS15002016-09-26
00852423006042PathwayMR-2597252016-09-26
00852423006059PathwayMR-2097102016-09-26
00852423006066PathwayMR-1597152016-09-26
00852423006073PathwayMR-1097002016-09-26
00852423006080Telesis925092502016-09-26
00852423006097Primus927592752016-09-26
00852423006103Synergy922592252016-09-26
00852423006127PathwayTR-1086102016-09-26
00852423006141Pathway® TR-2086202016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18