4cis® Instrument System

FDA UDI

Class I (US FDA UDI)

by Alphanox Co., Ltd.

Identity

Trade Name: 4CIS® INSTRUMENT SYSTEM FDA UDI
Generic Name: External spinal fixation system FDA UDI
Device Name: Reamer Sharp 4degree 10mm FDA UDI
Model / Reference: 5901-1043 FDA UDI
Description: Reamer Sharp 4degree 10mm FDA UDI

Identifiers

Catalog Number: 5901-1043 FDA UDI
Primary DI / UDI-DI: 08806373544774 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: External spinal fixation system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

Yes

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: External spinal fixation system

4cis® Instrument System by Alphanox Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Alphanox Co., Ltd.

Sources (1)

FDA UDI fdb6f9c8-fee1-4b21-bd29-9222a6a0c613 34 fields · synced May 30, 2026