FDA.reportPublic FDA data

AVANOS

Primary DI
10193493449016
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
FDI-17-75-4
Catalog number
FDI-17-75-4
Device description
COOLIEF* Cooled RF Fluid Delivery Introducers
Published
2020-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXIProbe, radiofrequency lesion

Product Code Classifications

CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10193493449016PackageGS120In Commercial Distribution
00193493449019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349344901610193493449016
00193493449019001934934490191934934490190193493449019

GMDN Terms

TermDefinition
Radio-frequency ablation system probe cannula, single-useA sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during RF ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10193494001695PROBLOC* II Insulated Regional Block Needle120008760HN3S-1002025-12-08
10193494001701PROBLOC* II Insulated Regional Block Needle120008761HN3S-1502025-12-08
10193494001718PROBLOC* II Insulated Regional Block Needle120008762HN3S-402025-12-08
10193494001725PROBLOC* II Insulated Regional Block Needle120008763HN3S-802025-12-08
10193494001732PROBLOC* II Insulated Regional block Needle120008753HN1-402025-11-28
10193494001749PROBLOC* II Insulated Regional block Needle120008754HN1-802025-11-28
10193494001756PROBLOC* II Insulated Regional block Needle120008755HN2-402025-11-28
10193494001763PROBLOC* II Insulated Regional block Needle120008756HN2-802025-11-28
10193494001770ECHOBRIGHT* ECHOGENIC Single Shot Tuohy Needle with Stimulating Cable120008759EBL18100TGC2025-11-28
10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008740EBL20100SG2025-11-28
10193494001794ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008741EBL20100SGC2025-11-28
10193494001800ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008742EBL20150SG2025-11-28
10193494001817ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008743EBL20150SGC2025-11-28
10193494001824ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008744EBL22050SG2025-11-28
10193494001831ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008745EBL22050SGC2025-11-28
10193494001848ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008746ELL18050SGC2025-11-28
10193494001855ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008747ELL18050TG2025-11-28
10193494001862ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008748ELL18050TGC2025-11-28
10193494001879ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008749ELL18100SGC2025-11-28
10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008750ELL18100TG2025-11-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
14895233602366LCCSLCCS Products LimitedGXI2025-11-17
00856895008153One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-09-01
00856895008139One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00856895008146One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00852454006424IntraceptRelievant Medsystems, Inc.GXI2025-08-04
00825114014879OWLDiros Technology IncGXI2025-07-16
04048223131947RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223131954RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132005RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132340TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132357TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132470RFTL SonoPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132647RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132692RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132715RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223049709RGNPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050132RFTLPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050484RFTL SonoPajunk GmbH MedizintechnologieGXI2025-01-30
00856895008634OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
40195327666355Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SCV181505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201515Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV221005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18