Simplex HV with Gentamicin

FDA UDI

Class II (US FDA UDI)

by OSARTIS GmbH

Identity

Trade Name: Simplex HV with Gentamicin FDA UDI
Generic Name: Orthopaedic cement, antimicrobial FDA UDI
Device Name: Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment. FDA UDI
Model / Reference: 6195-1-001 FDA UDI
Description: Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment. FDA UDI

Identifiers

Catalog Number: 6195-1-010 FDA UDI
Primary DI / UDI-DI: 04260056885761 FDA UDI
FDA Product Code: MBB FDA UDI
LOD FDA UDI
GMDN Term: Orthopaedic cement, antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 20 Milliliter FDA UDI
Weight — 40.8 Gram FDA UDI

Category: Orthopaedic cement, antimicrobial

Simplex HV with Gentamicin by OSARTIS GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement, antimicrobial.

PALACOS® — Heraeus Medical LLC · Class II
Refobacin® Bone Cement R — Biomet, Inc. · Class II
Unite Cement — OSTEOREMEDIES, LLC · Class II
MectaCem-X LV with Gentamicin — Tecres · Class II
BRAVO MV+G — G21 SRL · Class II
Simplex — Howmedica Osteonics Corp. · Class II
Cemex Genta HV — Tecres · Class II
PALACOS® — Heraeus Medical LLC · 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 II	Pending data

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Manufacturer

Manufacturer: OSARTIS GmbH

Sources (1)

FDA UDI fecad468-9d2e-4241-80de-6c548421c6f4 36 fields · synced May 30, 2026