Simplex HV with Gentamicin 6195-1-010

GUDID 24260056885765

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.

OSARTIS GmbH

Orthopaedic cement, medicated
Primary Device ID24260056885765
NIH Device Record Keyfecad468-9d2e-4241-80de-6c548421c6f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplex HV with Gentamicin
Version Model Number6195-1-001
Catalog Number6195-1-010
Company DUNS344261631
Company NameOSARTIS GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight40.8 Gram
Weight40.8 Gram

Operating and Storage Conditions

Handling Environment TemperatureBetween 17 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 17 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260056885761 [Primary]
GS114260056885768 [Package]
Contains: 04260056885761
Package: Dispenser box [10 Units]
In Commercial Distribution
GS124260056885765 [Package]
Contains: 14260056885768
Package: Shipping unit [2 Units]
In Commercial Distribution

FDA Product Code

MBBBone Cement, Antibiotic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-14
Device Publish Date2015-09-24

Devices Manufactured by OSARTIS GmbH

04260056882579 - BonOs HV2024-05-27 BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductil
04260056882623 - BonOs HV Genta2024-04-11 BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two sep
14260056880619 - EASYMIX® Nozzle slim2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
14260056880916 - EASYMIX® Nozzle revision2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
04260056881022 - EASYMIX® compressed air hose2022-12-09 EASYMIX® compressed air hose, 5 m, Medap wall coupling. The compressed air hoses connect the EASYMIX® vacuum pump to the compr
04260056881039 - EASYMIX® compressed air hose2022-12-09 EASYMIX® compressed air hose, 5 m, DIN 13260-2 wall coupling. Compressed air hoses connect the EASYMIX® vacuum pump to the com
04260056881633 - EASYMIX® vacuum pump I2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c
04260056881930 - EASYMIX® vacuum pump II2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.