Arm Needle holder

FDA UDI

Class II (US FDA UDI)

by Dex Surgical

Identity

Trade Name: Arm Needle holder FDA UDI
Generic Name: Endoscopic electromechanical surgical system FDA UDI
Device Name: The arm needle holder is a reusable (40 uses) endoscopic instrument. It is connected to the control handle and is used with the single-use Protection sleeve (ref. 2090-MDS). Each Arm is composed of a shaft, a connection cover and an articulated instrument followed by the needle holder tip that provides distal mobility. 1. Tilting the tip with respect to the axis of the shaft 2. Rotation of the tip around its own axis 3. Opening-closing the tip/needle holder FDA UDI
Model / Reference: B-1301 FDA UDI
Description: The arm needle holder is a reusable (40 uses) endoscopic instrument. It is connected to the control handle and is used with the single-use Protection sleeve (ref. 2090-MDS). Each Arm is composed of a shaft, a connection cover and an articulated instrument followed by the needle holder tip that provides distal mobility. 1. Tilting the tip with respect to the axis of the shaft 2. Rotation of the tip around its own axis 3. Opening-closing the tip/needle holder FDA UDI

Identifiers

Primary DI / UDI-DI: 03665772000060 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

Yes

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

Arm Needle holder 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
Control Handle Left — Dex Surgical
Control Unit — Dex Surgical
Control handle — Dex Surgical
Monopolar protection sleeve — Dex Surgical
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dex Surgical

Sources (1)

FDA UDI 0ac5aedf-ef8d-4a83-beee-19ad857adb19 34 fields · synced May 30, 2026