EASYMIX pro 02-0305

GUDID 04260056884429

Vacuum mixing system for mixing of PMMA bone cements

OSARTIS GmbH

Orthopaedic cement preparation/delivery kit
Primary Device ID04260056884429
NIH Device Record Keyed49b588-ba16-4d5d-903e-d07b4eb06a38
Commercial Distribution StatusIn Commercial Distribution
Brand NameEASYMIX pro
Version Model Number02-0305
Catalog Number02-0305
Company DUNS344261631
Company NameOSARTIS GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260056884412 [Primary]
GS104260056884429 [Package]
Contains: 04260056884412
Package: Shipping unit [10 Units]
In Commercial Distribution

FDA Product Code

JDZMixer, Cement, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-19
Device Publish Date2021-11-11

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

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