FDA.reportPublic FDA data

Intracept

Primary DI
10852454006124
Brand
Intracept
Company
RELIEVANT MEDSYSTEMS, INC.
Model
FG 0038
Catalog number
FG 0038
Device description
Intracept Flexible Bi-Polar RF Probe
Published
2018-04-01
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

Product Codes#

Code, Name table
CodeName
GXIProbe, Radiofrequency Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852454006124PackageGS13In Commercial Distribution
00852454006127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085245400612410852454006124
00852454006127008524540061278524540061270852454006127

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous electrosurgical probe, denervation, bipolarA sterile, semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a bipolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal bipolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
808344183
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
true
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 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
00852454006288RelievantFG 0052RLVRFG012022-12-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450452346ViaVerte™Merit Medical Systems, Inc.GXI2026-05-19
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
07613327601169OptaBlateSTRYKER CORPORATIONGXI2025-05-27
10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
10195327493172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
20763000835631AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835648AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835655AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
00193493000265COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000272COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000296AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000302AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000326COOLIEF*Avanos Medical, Inc.GXI2022-03-12
00193493985920AVANOS*Avanos Medical, Inc.GXI2022-03-12
00191506013097SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013103SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013110SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013127SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00193493000159AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000166AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000173AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000197AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000203AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478804AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478811AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478828AVANOSAvanos Medical, Inc.GXI2021-03-11