MUSE Console

FDA UDI

Class II (US FDA UDI)

by Medigus , Ltd.

Identity

Trade Name: MUSE Console FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The console contains: • A controller for the camera, ultrasonic range finder and various sensors. • A pump for insufflation and irrigation. • Power and controls for the LED FDA UDI
Model / Reference: 01 FDA UDI
Description: The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The console contains: • A controller for the camera, ultrasonic range finder and various sensors. • A pump for insufflation and irrigation. • Power and controls for the LED FDA UDI

Identifiers

Catalog Number: FMDB9000001 FDA UDI
Primary DI / UDI-DI: 07290014036529 FDA UDI
FDA Product Code: ODE FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Depth — 37 Centimeter FDA UDI
Width — 44 Centimeter FDA UDI
Height — 19 Centimeter FDA UDI

Category: General-purpose ultrasound imaging system

MUSE Console by Medigus , Ltd. — 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: Medigus , Ltd.

Sources (1)

FDA UDI 6dee4239-2a83-42f8-9967-da1a8d78ddcd 37 fields · synced May 31, 2026