BonOs R Genta 1x40

FDA UDI

Class II (US FDA UDI)

by OSARTIS GmbH

Identity

Trade Name: BonOs R Genta 1x40 FDA UDI
Generic Name: Orthopaedic cement, antimicrobial FDA UDI
Device Name: BonOs® R Genta 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. BonOs® R Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment. FDA UDI
Model / Reference: 01-0217 FDA UDI
Description: BonOs® R Genta 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. BonOs® R Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment. FDA UDI

Identifiers

Primary DI / UDI-DI: 04260056885679 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: Weight — 40.8 Gram FDA UDI

Category: Orthopaedic cement, antimicrobial

BonOs R Genta 1x40 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 4175c2fb-0500-48f5-869e-c15cc335e4a3 35 fields · synced Jun 1, 2026