FDA UDI
In Commercial Distribution
🇺🇸 United States
VENISTAR
DI: 08809306767868
·
Model: 3-VENI0030N
·
STARMED CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- VENISTAR
- Primary DI
- 08809306767868
- Version / Model
- 3-VENI0030N
- Company Name
- STARMED CO.,LTD
- Labeler DUNS
- 694699723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-29
- Public Version
- 1
- Public Version Date
- 2024-09-06
- Public Version Status
- New
- Public Device Record Key
- c2930c8e-d604-4007-a93e-ab60263e1097
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 62232 | Peripheral vascular radio-frequency ablation catheter | A sterile, rigid, hand-held luminal device intended to be percutaneously introduced into the peripheral vasculature as the distal component of a radio-frequency ablation system, to deliver radio-frequency current, in a bipolar configuration, for ablation of venous tissue to treat venous reflux disease (varicose veins). It typically includes an inner trocar/stylet to assist introduction and is maneuvered under external image guidance [e.g., ultrasound (US)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809306767865 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08809306767868 | GS1 | ||||
| Package | 28809306767862 | GS1 | Carton | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222997 | 000 |