Monopolar protection sleeve

FDA UDI

Class II (US FDA UDI)

by Dex Surgical

Identity

Trade Name: Monopolar protection sleeve FDA UDI
Generic Name: Endoscopic electromechanical surgical system FDA UDI
Device Name: Monopolar protection sleeve is designed to be installed onto Monopolar Arms B-1304, B-1505 and B-1506 and to remain there for the duration of the surgical procedure. It is provided non-sterile and is single use; it must be sterilize before the use. Its purpose is to protect the gear mechanism from its environment and guarantee the electrical insulation. It prevents the distal part of the arms (except for the tip) from coming into contact with the patient's tissues, thereby preventing the risk of lesions and burning subsequent to such contact. FDA UDI
Model / Reference: M-1304 FDA UDI
Description: Monopolar protection sleeve is designed to be installed onto Monopolar Arms B-1304, B-1505 and B-1506 and to remain there for the duration of the surgical procedure. It is provided non-sterile and is single use; it must be sterilize before the use. Its purpose is to protect the gear mechanism from its environment and guarantee the electrical insulation. It prevents the distal part of the arms (except for the tip) from coming into contact with the patient's tissues, thereby preventing the risk of lesions and burning subsequent to such contact. FDA UDI

Identifiers

Primary DI / UDI-DI: 03665772000046 FDA UDI
510(k) Number: K191878 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Endoscopic electromechanical surgical system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic electromechanical surgical system

Monopolar protection sleeve by Dex Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K191878 also covers:

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: Dex Surgical

Sources (1)

FDA UDI 607ef8ca-39a2-4f8d-a9f8-718bad7d16ff 34 fields · synced May 31, 2026