FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoart
DI: E307229310070
·
Model: MONOART EM21
·
EURONDA SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Monoart
- Primary DI
- E307229310070
- Version / Model
- MONOART EM21
- Catalog Number
- 22931007
- Company Name
- EURONDA SPA
- Labeler DUNS
- 428755441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-06
- Public Version
- 1
- Public Version Date
- 2019-12-16
- Public Version Status
- New
- Public Device Record Key
- fc451d4a-2ae3-4d2a-9ef6-0db6bf09bf15
Device Description
Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: pink
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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
- No
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 |
|---|---|---|---|---|
| 38759 | Dental suction system cannula, reusable | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | E307229310072 | HIBCC | carton | 10 | In Commercial Distribution | |
| Package | E307229310071 | HIBCC | box | 10 | In Commercial Distribution | |
| Primary | E307229310070 | HIBCC |