FDA UDI
In Commercial Distribution
🇺🇸 United States
Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)
DI: 03665415002161
·
Model: VP3S
·
LAMIDEY NOURY MEDICAL
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)
- Primary DI
- 03665415002161
- Version / Model
- VP3S
- Catalog Number
- VP3S
- Company Name
- LAMIDEY NOURY MEDICAL
- Labeler DUNS
- 266955967
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-21
- Public Version
- 1
- Public Version Date
- 2023-05-01
- Public Version Status
- New
- Public Device Record Key
- 588f8007-cfe1-4c3f-b4bd-e011537d8395
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 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| FDC | Resectoscope, Working Element | Gastroenterology, Urology | 876.1500 | 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 | 03665415002161 | GS1 |
Customer Contacts
- Phone
- +33169206969
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213135 | 000 |