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4cis® Instrument System

FDA UDI

Class I (US FDA UDI)

by Alphanox Co., Ltd.

Identity

Trade Name
4CIS® INSTRUMENT SYSTEM FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
4CIS® Chiron Screw Driver Navigation Type FDA UDI
Model / Reference
4901-8118 FDA UDI
Description
4CIS® Chiron Screw Driver Navigation Type FDA UDI

Identifiers

Catalog Number
4901-8118 FDA UDI
Primary DI / UDI-DI
08806373594212 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, reusable

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

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphanox Co., Ltd.

Sources (1)

  • FDA UDI bde90e3e-31d1-4530-819b-022ee651a2f6 34 fields · synced May 30, 2026