FDA.reportPublic FDA data

IonicRF™

Primary DI
05415067033833
Brand
IonicRF™
Company
ST. JUDE MEDICAL, INC.
Model
RF-POLE
Catalog number
RF-POLE
Device description
Generator Pole Mount
Published
2020-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXDGenerator, lesion, radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201610000IonicRF GeneratorABBOTT MEDICAL2020-10-21GXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067033833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067033833054150670338335415067033833

GMDN Terms#

Term, Definition table
TermDefinition
Frame/rail/pole device holderA clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22
05415067016683NA231623162015-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506048464GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048518GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048563GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059309GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059330GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059347GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059354GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
05415067049650NAST. JUDE MEDICAL, INC.GXD2024-03-26
00856895008498OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008504OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008511OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008528OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008535OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008559OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008566OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
10195327563424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
40195327563425Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
05415067034519N/AST. JUDE MEDICAL, INC.GXD2023-10-25
15415067034516N/AST. JUDE MEDICAL, INC.GXD2023-10-25
00825114000032OWLDiros Technology IncGXD2023-06-19
00852454006288RelievantRelievant Medsystems, Inc.GXD2022-12-09
00193493000692COOLIEF* Quad Pump Connector CableAvanos Medical, Inc.GXD2022-10-17
00193493000340AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000357AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000401AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493000418AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493473021COOLIEF* Basic-R GeneratorAvanos Medical, Inc.GXD2021-01-27
00193493473038COOLIEF* Cooled RF Advanced-R GeneratorAvanos Medical, Inc.GXD2021-01-27
05415067029317IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-14
00193493473014COOLIEF* Cooled RF Advanced GeneratorAvanos Medical, Inc.GXD2020-10-16