FDA UDI
In Commercial Distribution
🇺🇸 United States
DORO® NON-STICK Bipolar Forceps
DI: 04250435505342
·
Model: 5064.012
·
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DORO® NON-STICK Bipolar Forceps
- Primary DI
- 04250435505342
- Version / Model
- 5064.012
- Company Name
- pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
- Labeler DUNS
- 313517922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-06
- Public Version
- 4
- Public Version Date
- 2021-03-11
- Public Version Status
- Update
- Public Device Record Key
- 392b7e17-8009-46ab-8e55-8a464b5e5229
Device Description
DORO® NON-STICK Bipolar Straight 19 cm (7.5"), tip 0.4 mm
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 47848 | Open-surgery electrosurgical handpiece/electrode, bipolar, reusable | A rigid combined electrosurgical handpiece and bipolar 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 | 04250435505342 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070997 | 000 |