FDA UDI
In Commercial Distribution
🇺🇸 United States
EASYMIX cement injector
DI: 04260056881251
·
Model: 02-0504-04
·
OSARTIS GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EASYMIX cement injector
- Primary DI
- 04260056881251
- Version / Model
- 02-0504-04
- Catalog Number
- 02-0504-04
- Company Name
- OSARTIS GmbH
- Labeler DUNS
- 344261631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 1
- Public Version Date
- 2022-12-06
- Public Version Status
- New
- Public Device Record Key
- 586aab3f-24f2-45e7-b58f-e7d47653556c
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIH | Dispenser, Cement | Orthopedic | 888.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47703 | Orthopaedic cement/bone filler dispensing gun | A hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260056881251 | GS1 |