Protection sleeve

FDA UDI

Class II (US FDA UDI)

by Dex Surgical

Identity

Trade Name: Protection sleeve FDA UDI
Generic Name: Endoscopic electromechanical surgical system FDA UDI
Device Name: Protection sleeve 2090-MDS is designed to be placed on the Needle holder arm and to remain there for the duration of the surgical procedure. Its purpose is to protect the gear mechanism from its environment. It also helps prevent the gears from coming into contact with the patient's tissues, thereby preventing the risk of lesion formation subsequent to such mechanical contact. It is provided non-sterile and is single use; it must be sterilize before the use. FDA UDI
Model / Reference: 2090-MDS FDA UDI
Description: Protection sleeve 2090-MDS is designed to be placed on the Needle holder arm and to remain there for the duration of the surgical procedure. Its purpose is to protect the gear mechanism from its environment. It also helps prevent the gears from coming into contact with the patient's tissues, thereby preventing the risk of lesion formation subsequent to such mechanical contact. It is provided non-sterile and is single use; it must be sterilize before the use. FDA UDI

Identifiers

Primary DI / UDI-DI: 03665772000039 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

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

Similar devices

Also classified as Endoscopic electromechanical surgical system.

Anovo Surgeon Console — MOMENTIS SURGICAL LTD · Class II
Anovo Surgeon Console and Anovo Power cable — MOMENTIS SURGICAL LTD · Class II
Anovo Surgical System (Surgeon Console, RCU and cables) — MOMENTIS SURGICAL LTD · Class II
HandX — Human Xtensions , Ltd. · Class II
Self-Righting Needle Holder — Human Xtensions , Ltd. · Class II
HandX Needle Holder 5mm — Human Xtensions , Ltd. · Class II
HandX Disposables — Human Xtensions , Ltd. · Class II
HandX Fenestrated Grasper 5mm — Human Xtensions , Ltd. · Class II

Cleared under the same submission

K191878 also covers:

Arm Monopolar Maryland — Dex Surgical
Arm Monopolar hook — Dex Surgical
Arm Monopolar scissors — Dex Surgical
Arm Needle holder — Dex Surgical
Control Handle Left — Dex Surgical
Control Unit — Dex Surgical
Control handle — Dex Surgical
Monopolar protection sleeve — Dex Surgical
Sleeve applicator tool — Dex Surgical

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 a207ba58-9005-44c2-9792-9d41d3458d3d 34 fields · synced May 30, 2026