FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Working element for FRONT load bipolar electrode
DI: 03760263240175
·
Model: Passive working element ACMI compatible
·
CHIRURGIE INNOVATION
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Working element for FRONT load bipolar electrode
- Primary DI
- 03760263240175
- Version / Model
- Passive working element ACMI compatible
- Catalog Number
- VP4
- Company Name
- CHIRURGIE INNOVATION
- Labeler DUNS
- 264592326
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-09
- Public Version
- 2
- Public Version Date
- 2022-04-28
- Public Version Status
- Update
- Public Device Record Key
- 1f152422-c847-4303-a64c-0b3831be9c83
- Distribution End Date
- 2022-03-08
Device Description
(Front load ; Fr26)
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | 876.4300 | 2 |
| FDC | Resectoscope, Working Element | Gastroenterology, Urology | 876.1500 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37085 | Rigid endoscope working guide | An endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760263240175 | GS1 |