FDA.reportPublic FDA data

Relievant

Primary DI
00852454006288
Brand
Relievant
Company
Relievant Medsystems, Inc.
Model
FG 0052
Catalog number
RLVRFG01
Device description
Relievant RFG
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXDGenerator, Lesion, Radiofrequency

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852454006288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852454006288008524540062888524540062880852454006288

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099324362
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852454006424IntraceptRLV00652025-08-04
00852454006004IntraceptFG 0043RLV RFP052019-01-25
00852454006035IntraceptFG 0046RLV AKA052018-04-01
00852454006189IntraceptFG 0060RLV AK052019-01-15
00852454006196IntraceptRLV PKRLV PK2019-01-25
00852454006028IntraceptFG 0045RLV AKT052018-04-01
00852454006080IntraceptFG 0054RLV AKB052018-04-01
00852454006127IntraceptFG 0038FG 00382018-04-01
00852454006301IntraceptRLV 00452023-06-09
00852454006226IntraceptRLV 00552023-04-20
00852454006233IntraceptRLV 00202023-04-20
00852454006240IntraceptRLV 00352023-04-20
00852454006257IntraceptRLV 00752023-04-20
00852454006219Intracept RF ProbeRLV 00152023-03-07
00852454006295Intracept RF ProbeRLV 00152023-02-24
00852454006066RelievantFG 0052RLV RFG012018-04-01
00852454006141IntraceptRLV PKTLRRLV PKTLR2018-08-01
00852454006158IntraceptRLV PKBLRRLV PKBLR2018-08-01
10852454006001IntraceptFG 0043RLV RFP052019-01-25
10852454006186IntraceptFG 0060RLV AK052019-01-15

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
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
05415067033833IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-11
00193493473014COOLIEF* Cooled RF Advanced GeneratorAvanos Medical, Inc.GXD2020-10-16