Identity
- Trade Name
- MetaSTAR® FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Model / Reference
- 00884450296011 FDA UDI
Identifiers
- Catalog Number
- 3195/A FDA UDI
- Primary DI / UDI-DI
- 00884450296011 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator 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
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Percutaneous radio-frequency ablation system generator
MetaSTAR is a highly advanced, non-invasive electrosurgical device designed for precise focal ablation of non-cardiac tissues using radio-frequency (RF) electrical current. Developed by Merit Medical Systems, Inc., this Percutaneous Radio-Frequency Ablation System Generator is intended for coagulation purposes, but not specifically designed for electrosurgical cutting tasks.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI c5390306-05de-4c7e-803f-0dfd17738eaf 33 fields · synced Jul 10, 2026