Vortex

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: VORTEX FDA UDI
Generic Name: Orthopaedic cement preparation/delivery kit FDA UDI
Device Name: VORTEX RE-USE KIT FDA UDI
Model / Reference: 71270071 FDA UDI
Description: VORTEX RE-USE KIT FDA UDI

Identifiers

Catalog Number: 71270071 FDA UDI
Primary DI / UDI-DI: 03596010456427 FDA UDI
FDA Product Code: JDZ FDA UDI
GMDN Term: Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic cement preparation/delivery kit

Vortex by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CEMEX SYSTEM FAST 70G — Tecres · Class II
PicoMix Bowl — G21 SRL · 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

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 1db52c57-0b11-4ce0-ab1f-af792d7d0499 35 fields · synced Jun 6, 2026