FDA UDI
In Commercial Distribution
🇺🇸 United States
VESALIUS STERILE pinza bipolare a baionetta NON STICK
DI: 08034055293874
·
Model: STERILE, L=165mm T=1mm
·
TELEA ELECTRONIC ENGEENERING SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VESALIUS STERILE pinza bipolare a baionetta NON STICK
- Primary DI
- 08034055293874
- Version / Model
- STERILE, L=165mm T=1mm
- Catalog Number
- 2606518
- Company Name
- TELEA ELECTRONIC ENGEENERING SRL
- Labeler DUNS
- 435331459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-08-23
- Public Version Status
- Update
- Public Device Record Key
- 53d92b59-bc34-4402-8d31-e8330e1afbe1
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
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56296 | Open-surgery electrosurgical handpiece/electrode, bipolar, single-use | A sterile 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 8034055297667 | GS1 | DOUBLE ENVELOPE | 5 | In Commercial Distribution | |
| Primary | 08034055293874 | GS1 |