FDA.reportPublic FDA data

Simplex HV with Gentamicin

Primary DI
24260056885765
Brand
Simplex HV with Gentamicin
Company
OSARTIS GmbH
Model
6195-1-001
Catalog number
6195-1-010
Device 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.
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBBBone Cement, AntibioticOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14260056885768PackageGS110In Commercial Distribution
24260056885765PackageGS12In Commercial Distribution
04260056885761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426005688576814260056885768
2426005688576524260056885765
04260056885761042600568857614260056885761

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, medicatedA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight40.8Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature17 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344261631
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260056880674XPERIENCE Advanced Surgical IrrigationSL-0005MC-SL-0005-102026-04-01
04260056880643BLASTX®WG-0001MC-WG.0001-122026-02-19
14260056880640BLASTX®WG-0001MC-WG.0001-122026-02-19
04260056882579BonOs HV1x4001-01622024-05-17
04260056882623BonOs HV Genta1x4001-02622024-04-03
04260056880759Vertecem II Cement Kit08.702.017S08.702.017S2015-10-21
04260056883231BonOs Inject01-03092015-10-02
04260056880612EASYMIX® Nozzle slim02-010402-01042022-12-01
04260056880919EASYMIX® Nozzle revision02-010502-01052022-12-01
14260056880619EASYMIX® Nozzle slim02-010402-01042022-12-01
14260056880916EASYMIX® Nozzle revision02-010502-01052022-12-01
04260056881022EASYMIX® compressed air hose02-020502-02052022-12-01
04260056881039EASYMIX® compressed air hose02-020602-02062022-12-01
04260056881633EASYMIX® vacuum pump I02-040102-04012022-12-01
04260056881930EASYMIX® vacuum pump II02-020102-02012022-12-01
04260056881251EASYMIX cement injector02-0504-0402-0504-042022-11-28
04260056884412EASYMIX pro02-030502-03052021-11-11
04260056884429EASYMIX pro02-030502-03052021-11-11
04260056881565ManuMix02-060102-06022021-10-12
04260056881572ManuMix02-060102-06022021-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868551611StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551635StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551642StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551697StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551703STAGEONE SELECTBiomet Orthopedics, LLCMBB2026-03-17
08031497003955Interspace GV Hip Spacer 46TECRES SPAMBB2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAMBB2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAMBB2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAMBB2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAMBB2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAMBB2026-02-11
03760177044326Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044333Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044340Signature -x Cement TEKNIMEDMBB2026-01-23
08058964729217CeMend Shoulder SpacerG21 SRLMBB2025-12-19
08058964729224CeMend Shoulder SpacerG21 SRLMBB2025-12-19
08058964729231CeMend Shoulder SpacerG21 SRLMBB2025-12-19
08058964729248CeMend Shoulder SpacerG21 SRLMBB2025-12-19
03760177040090GENTAFIXTEKNIMEDMBB2025-09-02
03760177040137GENTAFIXTEKNIMEDMBB2025-09-02
03760177043176GENTAFIXTEKNIMEDMBB2025-09-02
08058964728876CeMend Mold BaseG21 SRLMBB2025-03-18
08058964728883CeMend 8-42 mold insert pressG21 SRLMBB2025-03-18
08058964728890CeMend 10-42 mold insert pressG21 SRLMBB2025-03-18
08058964728906CeMend 10-48 mold insert pressG21 SRLMBB2025-03-18