FDA.reportPublic FDA data

EASYMIX® Nozzle revision

Primary DI
04260056880919
Brand
EASYMIX® Nozzle revision
Company
OSARTIS GmbH
Model
02-0105
Catalog number
02-0105
Device description
The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle.The EASYMIX® Nozzle revision is longer and of larger diameter than the EASYMIX® standard nozzle.
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDZMixer, Cement, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14260056880916PackageGS110In Commercial Distribution
04260056880919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426005688091614260056880916
04260056880919042600568809194260056880919

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length280Millimeter
Outer Diameter13Millimeter

Regulatory Flags#

DUNS number
344261631
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260056880667XPERIENCE Advanced Surgical Irrigation008875010000887510002026-07-28
04260056880650BLASTXMC-WG-0003-40MC-WG-0003-402026-07-12
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456203163JMUJMU DENTAL, INCJDZ2026-08-18
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00840456223635JMUJMU DENTAL, INCJDZ2026-08-18
00840456223642JMUJMU DENTAL, INCJDZ2026-08-18
00840456223659JMUJMU DENTAL, INCJDZ2026-08-18
00840456223789JMUJMU DENTAL, INCJDZ2026-08-18
00840456223796JMUJMU DENTAL, INCJDZ2026-08-18
00840456223802JMUJMU DENTAL, INCJDZ2026-08-18
D125705550R4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
D125705550W4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
06934415056632ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
06934415056649ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
04250203943482QuattroMixJoline GmbH & Co. KGJDZ2026-03-03
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15060238201749HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201756Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201787 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10