Who else makes this device?

Name: Coolief* Cooled RF Introducer
Brand: Coolief* Cooled RF Introducer

Coolief* Cooled RF Introducer · Probe, Radiofrequency Lesion → Neurology

1manufacturer

2catalogue 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.

Chinese manufacturers registered for FDA product code GXI
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for Coolief* Cooled RF Introducer
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
Record published	2017-01-09
Record revised	2023-06-22 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Coolief* Cooled RF Introducer
Catalogue number	Size	Status
44208		In distribution
44207		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance	Decision date
K203066	2020-12-22

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
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

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.

Coolief* Cooled RF Introducer