FDA UDI
In Commercial Distribution
🇺🇸 United States
EASYMIX® Nozzle slim
DI: 04260056880612
·
Model: 02-0104
·
OSARTIS GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EASYMIX® Nozzle slim
- Primary DI
- 04260056880612
- Version / Model
- 02-0104
- Catalog Number
- 02-0104
- Company Name
- OSARTIS GmbH
- Labeler DUNS
- 344261631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 1
- Public Version Date
- 2022-12-09
- Public Version Status
- New
- Public Device Record Key
- 3feaf6c8-2580-426b-b81c-ba58995cb698
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 slim is shorter and of smaller diameter than the standard nozzle provided with the EASYMIX® vacuum mixing system.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | 888.4210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45253 | Orthopaedic cement preparation/delivery kit | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14260056880619 | GS1 | Carton box | 10 | In Commercial Distribution | |
| Primary | 04260056880612 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8 | Millimeter | |
| Length | 173 | Millimeter |