Identity
- Trade Name
- EASYMIX cement injector FDA UDI
- Generic Name
- Orthopaedic cement/bone filler dispensing gun FDA UDI
- Device Name
- The 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. FDA UDI
- Model / Reference
- 02-0504-04 FDA UDI
- Description
- The 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. FDA UDI
Identifiers
- Catalog Number
- 02-0504-04 FDA UDI
- Primary DI / UDI-DI
- 04260056881251 FDA UDI
- FDA Product Code
- KIH FDA UDI
- GMDN Term
- Orthopaedic cement/bone filler dispensing gun FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement/bone filler dispensing gun
EASYMIX cement injector by OSARTIS GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement/bone filler dispensing gun.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSARTIS GmbH
Sources (1)
- FDA UDI 586aab3f-24f2-45e7-b58f-e7d47653556c 34 fields · synced Jun 8, 2026