ASSISTO® Arm-System

FDA UDI

Class I (US FDA UDI)

by Geomed Medizin-Technik GmbH & Co. KG

Identity

Trade Name: ASSISTO® Arm-System FDA UDI
Generic Name: Medical device service rail clamp FDA UDI
Device Name: ASSISTO CLAMP SOCKET K2 50MM INSUL 4,5K FDA UDI
Model / Reference: CI 310-50-01 FDA UDI
Description: ASSISTO CLAMP SOCKET K2 50MM INSUL 4,5K FDA UDI

Identifiers

Primary DI / UDI-DI: 14049679079583 FDA UDI
FDA Product Code: FWZ FDA UDI
GMDN Term: Medical device service rail clamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4950 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medical device service rail clamp

ASSISTO® Arm-System by Geomed Medizin-Technik GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical device service rail clamp.

Infinity Pole Clamp — ZEVEX INTERNATIONAL, INC. · Class II
WANClamp, EndoEZ Clamp — Well Lead Medical Co., Ltd · Class I
D130/D131 KIDS Arterial Filter — SORIN GROUP ITALIA SRL · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Bracket — LivaNova USA, Inc. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
CAPIOX — Terumo Corp. · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Geomed Medizin-Technik GmbH & Co. KG

Sources (1)

FDA UDI f820a580-57c7-4e3e-83bb-f2b67af5182c 33 fields · synced May 30, 2026