Synject

FDA UDI

Class I (US FDA UDI)

by Synthes

Identity

Trade Name: SYNJECT FDA UDI
Generic Name: Orthopaedic cement preparation/delivery kit FDA UDI
Device Name: SYNJECT CARTRIDGE-STERILE FDA UDI
Model / Reference: 03.702.520S FDA UDI
Description: SYNJECT CARTRIDGE-STERILE FDA UDI

Identifiers

Catalog Number: 03702520S FDA UDI
Primary DI / UDI-DI: 10705034721927 FDA UDI
FDA Product Code: OAR FDA UDI
GMDN Term: Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4200 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

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

Synject by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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VORTEX — Smith & Nephew, Inc. · Class I
StabiliT® — Merit Medical Systems, Inc. · Class II
CEMEX SYSTEM FAST 70G — Tecres · Class II

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: Synthes

Sources (1)

FDA UDI d2d8b51f-961e-456b-8bc7-3de4387f8523 35 fields · synced May 30, 2026