FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Endovenous Radiofrequency Ablation (RFA) Catheter
DI: 08600360005008
·
Model: VEN-7-100
·
Vein360 LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Endovenous Radiofrequency Ablation (RFA) Catheter
- Primary DI
- 08600360005008
- Version / Model
- VEN-7-100
- Catalog Number
- VEN-7-100
- Company Name
- Vein360 LLC
- Labeler DUNS
- 080926907
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-17
- Public Version
- 3
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- be6b80e3-2b90-4072-91c9-cca55c4f12ba
- Distribution End Date
- 2023-11-08
Device Description
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
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 |
|---|---|---|---|---|
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | General, Plastic Surgery | 878.4400 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57972 | Radio-frequency ablation system | An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08600360005008 | GS1 |
Customer Contacts
- Phone
- 5138540239
- [email protected]