Identity
- Trade Name
- SpineSTAR® FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Model / Reference
- 00884450296035 FDA UDI
Identifiers
- Catalog Number
- 3544/A FDA UDI
- Primary DI / UDI-DI
- 00884450296035 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency ablation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radio-frequency ablation system
The SpineSTAR device is a radio-frequency ablation system used for precise and controlled tissue heating, intended for coagulation purposes. It features a mains electricity-powered RF current generator, controls, cables, and an electrosurgical probe, catheter, or handpiece with electrode(s).
Similar devices
Also classified as Radio-frequency ablation system.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Cavi di connessione — ADVANCED MEDICAL SYSTEMS GROUP S.R.L. · Class I
- RF Ablation Electrode Kits — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
- CP-16 TIP — Jeisys Medical Inc. · Class IIb
- 10THERMA Electrode — TENTECH Inc. · Class IIb
- Acessa ProVu PFG Table Clamp — ACESSA HEALTH INC. · Class II
- DIAMOND TIP — Jeisys Medical Inc. · Class IIb
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 578fff21-3411-4be8-af03-1955990d34fa 34 fields · synced Jul 26, 2026