Coolief*
COOLIEF* Cooled Radiofrequency Peristaltic Pump Connector Cable
1manufacturer
5catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K053082 |
| Record published | 2022-03-17 |
| Record revised | 2026-01-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20 |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TDX-PMG-PPU | 20 | In distribution | |
| CRI-17-150-6 | In distribution | ||
| CRX-BAY-MCRF | In distribution | ||
| CRX-BAY-CRP | Withdrawn | ||
| TDX-Y-TSW-TDP2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OWL | Diros Technology, Inc. | 345 |
| Probe, Radiofrequency Lesion | Boston Scientific Neuromodulation Corporation | 175 |
| Halyard | Avanos Medical, Inc. | 156 |
| Lccs | Lccs Products Limited | 101 |
| Epimed | Epimed International, Inc. | 100 |
| Avanos | Avanos Medical, Inc. | 89 |
| NeuroTherm™ | Neurotherm, Inc. | 87 |
| Probe, Radiofrequency Lesion | St. Jude Medical | 66 |
| cannulaRFK | Cosman Medical, Inc. | 56 |
| Rftl | Pajunk Gmbh Medizintechnologie | 54 |
| Radiofrequency (RF) Needle | Spectra Medical Devices, LLC | 49 |
| cannulaCC | Cosman Medical, Inc. | 47 |
Showing 12 of 85. All products under Probe, Radiofrequency Lesion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203066 | 2020-12-22 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | 510(k) number | 2016-06-16 | Class II | Process control | Mismatch between the length of the RF electrode (probe) and the cannula (introducer), | 51 kits | 2016-09-08 |
| Baylis Medical Technologies Inc. | 510(k) number | 2010-05-12 | Not classified | Error in labeling | Name of the device reflected on the product packing sleeve is incorrect. | 58 | 2010-10-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.