MUSE Endostapler

FDA UDI

Class II (US FDA UDI)

by Medigus , Ltd.

Identity

Trade Name: MUSE Endostapler FDA UDI
Generic Name: Endoscopic manual linear stapler FDA UDI
Device Name: The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated accessories including a monitor and staple cartridges. The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. FDA UDI
Model / Reference: 01 FDA UDI
Description: The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated accessories including a monitor and staple cartridges. The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. FDA UDI

Identifiers

Catalog Number: MMAA1006002 FDA UDI
Primary DI / UDI-DI: 07290014036062 FDA UDI
FDA Product Code: ODE FDA UDI
GMDN Term: Endoscopic manual linear stapler 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 15.5 Millimeter FDA UDI
Weight — 2 Kilogram FDA UDI
Length — 295 Centimeter FDA UDI

Category: Endoscopic manual linear stapler

MUSE Endostapler 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 b61c85f0-731f-472a-9c12-c91dfc5f14dc 37 fields · synced Jun 8, 2026