FDA UDI
In Commercial Distribution
🇺🇸 United States
ABLATOR / EFLEX
DI: 03596010470669
·
Model: 7209666
·
Smith & Nephew, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ABLATOR / EFLEX
- Primary DI
- 03596010470669
- Version / Model
- 7209666
- Catalog Number
- 7209666
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-30
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 3504cd76-e517-4d93-be5f-12091ac83937
Device Description
ABLATOR E-FLEX VULCAN INTEGRATED
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
- 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 |
|---|---|---|---|---|
| HRX | ARTHROSCOPE | Orthopedic | 888.1100 | 2 |
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32531 | Radio-frequency ablation system probe, reusable | A hand-held surgical device designed to connect to a radio-frequency ablation system generator to deliver radio-frequency (RF) energy to a targeted operative site for soft-tissue coagulation/ablation (i.e., thermal ablation, therapeutic lesion, or denervation). It is intended to be used in percutaneous, laparoscopic, or intraoperative procedures to ablate tissue typically in the brain/nerves, kidney, liver, and/or in small or metastatic tumours. The device typically includes multiple electrodes that extend from its tip, once deployed, and which cover the site to be treated. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010470669 | GS1 |
Customer Contacts
- Phone
- +1(800)821-5700
- [email protected]