Morpheus

FDA UDI

Class II (US FDA UDI)

by Prometheus Group Of New Hampshire Limited, The

Identity

Trade Name: Morpheus FDA UDI
Generic Name: Ultrasound imaging system operator console FDA UDI
Device Name: Morpheus® Control Module FDA UDI
Model / Reference: MOR0118 FDA UDI
Description: Morpheus® Control Module FDA UDI

Identifiers

Catalog Number: MOR0118 FDA UDI
Primary DI / UDI-DI: 00852423006004 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
KPI FDA UDI
GMDN Term: Ultrasound imaging system operator console FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
876.5320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology DICOM image processing application software Urodynamic measurement system Ultrasound imaging system operator console

Morpheus by Prometheus Group Of New Hampshire Limited, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Prometheus Group Of New Hampshire Limited, The

Sources (1)

FDA UDI 5c4d1e09-92ae-4c1b-ad4e-8f3657600843 35 fields · synced May 30, 2026