| Primary Device ID | 04260056881251 |
| NIH Device Record Key | 586aab3f-24f2-45e7-b58f-e7d47653556c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EASYMIX cement injector |
| Version Model Number | 02-0504-04 |
| Catalog Number | 02-0504-04 |
| Company DUNS | 344261631 |
| Company Name | OSARTIS GmbH |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260056881251 [Primary] |
| KIH | Dispenser, Cement |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04260056881251]
Moist Heat or Steam Sterilization
[04260056881251]
Moist Heat or Steam Sterilization
[04260056881251]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-06 |
| Device Publish Date | 2022-11-28 |
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| 14260056880619 - EASYMIX® Nozzle slim | 2022-12-09 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 revision | 2022-12-09 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 hose | 2022-12-09 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 hose | 2022-12-09 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 I | 2022-12-09 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 II | 2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c |
| 04260056881251 - EASYMIX cement injector | 2022-12-06The cement injector is used to apply bone cements. It is operated manually and provides a secure environment for the cartridge and a constant discharge of bone cement during application. It is made of high-grade stainless steel and designed for reuse and resterilisation. The EASYMIX® cement injector is intended to be used with the EASYMIX® mixing system to apply PMMA bone cements. |
| 04260056881251 - EASYMIX cement injector | 2022-12-06 The cement injector is used to apply bone cements. It is operated manually and provides a secure environment for the cartridge a |