Identity
- Trade Name
- COOLIEF* Basic Generator FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- COOLIEF* Basic Generator FDA UDI
- Model / Reference
- CRG-BASIC FDA UDI
- Description
- COOLIEF* Basic Generator FDA UDI
Identifiers
- Catalog Number
- CRG-BASIC FDA UDI
- Primary DI / UDI-DI
- 00193493473090 FDA UDI
- 510(k) Number
- K192491 FDA UDI
- FDA Product Code
- GXD FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Percutaneous radio-frequency ablation system generator
COOLIEF* Basic Generator by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation system generator.
- OneRF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
- Mygen™ RF Generator M-3004 — RF Medical Co., Ltd. · Class II
- ATTIVA — ITALIAN ENGINEERING SRL · Class II
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Maestro 4000™ Controller — Boston Scientific · Class III
- SmartAblate™ System CoolFlow® Pump Cable — Stockert GmbH · Class III
- InSeal Sealer/Divider — Innolcon Medical Technology (Suzhou) Co., Ltd. · Class IIb
- Electrosurgical Pencil, Button Switch — DEROYAL INDUSTRIES, INC. · Class IIb
Cleared under the same submission
K192491 also covers:
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- COOLIEF* Basic-R Generator — Avanos Medical, Inc.
- COOLIEF* Cooled RF Advanced Generator — Avanos Medical, Inc.
- COOLIEF* Cooled RF Advanced-R Generator — Avanos Medical, Inc.
- COOLIEF* Multi-Cooled RF Therapy Cable — Avanos Medical, Inc.
- COOLIEF* Quad Pump Connector Cable — Avanos Medical, Inc.
- COOLIEF* Quad Pump Unit — Avanos Medical, Inc.
- COOLIEF* TRANDISCAL* Radiofrequency Therapy Cable — Avanos Medical, Inc.
- Multi-RF Therapy Cable — Avanos Medical, Inc.
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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 23e20adf-ea07-45fc-b9ce-f704127e3422 36 fields · synced Jun 9, 2026