FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED
DI: 00842180136403
·
Model: 5002-LESDIC
·
ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELMED
- Primary DI
- 00842180136403
- Version / Model
- 5002-LESDIC
- Catalog Number
- 5002-LESDIC
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-12
- Public Version
- 1
- Public Version Date
- 2019-09-20
- Public Version Status
- New
- Public Device Record Key
- 145e54b5-128d-493b-80be-b68ec7a246b3
Device Description
MONOPOLAR CUT/COAGULATION RF-CURETTE WITH IRRIGATION AND SUCTION. INSULATED STAINLESS STEEL-REUSABLE, STANDARD STRAIGHT TIP, 4MM DIA., 11CM WORKING LENGTH, RIGHT SIDE SUCTION PORT, 26.5CM OVERALL LENGTH, DESIGN BY DR. GIANCARLO LUIGI
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61870 | Open-surgery electrosurgical handpiece/electrode, monopolar, reusable | A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842180136403 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]