Sleeve applicator tool

FDA UDI

Class II (US FDA UDI)

by Dex Surgical

Identity

Trade Name: Sleeve applicator tool FDA UDI
Generic Name: Endoscopic electromechanical surgical system FDA UDI
Device Name: The Sleeve applicator tool purpose is to help the installation of Protection sleeve 2090-MDS onto the tip of Arm Needle holder B-1301 FDA UDI
Model / Reference: P46732 FDA UDI
Description: The Sleeve applicator tool purpose is to help the installation of Protection sleeve 2090-MDS onto the tip of Arm Needle holder B-1301 FDA UDI

Identifiers

Primary DI / UDI-DI: 03665772000053 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic electromechanical surgical system

Sleeve applicator tool 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
Protection sleeve — 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 0beabf2a-c7d9-41ac-82cc-1979665aed42 34 fields · synced May 30, 2026