Euromi
Basic Information
- Brand Name
- Euromi
- Primary DI
- 03701416203012
- Version / Model
- 1214L3GW-3250
- Catalog Number
- 1214L3GW-3250
- Company Name
- Euromi
- Labeler DUNS
- 505804302
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-10
- Public Version
- 1
- Public Version Date
- 2025-10-20
- Public Version Status
- New
- Public Device Record Key
- 9ac85761-9828-48cc-9bbe-1e078acc728e
Device Description
The cannulas are reusable medical devices intended to be used by healthcare professionals for surgical or aesthetic applications. They are designed for the injection, irrigation, or aspiration of biological fluids, depending on their configuration. Manufactured from stainless steel or tungsten, they provide excellent mechanical and chemical resistance, ensuring durability and compatibility with standard cleaning, disinfection, and sterilization processes commonly used in the medical field. The cannulas are supplied non-sterile and must be thoroughly cleaned and sterilized before each use. They are available in various lengths, diameters, and tip configurations depending on the intended use, and are designed to ensure precise, safe, and comfortable handling.
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45414 | Liposuction system cannula, reusable | A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701416203012 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010311 | 000 |