Home GUDID 15415067029031 NA
Primary DI 15415067029031
Brand NA
Company ST. JUDE MEDICAL, INC.
Model RFDE-15
Catalog number RFDE-15
Device description Disposable Radiofrequency Electrode
Published 2017-04-10
Public version status Update
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 Code Name GXI PROBE, RADIOFREQUENCY LESION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXI Probe, Radiofrequency Lesion Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15415067029031 Package GS1 5 In Commercial Distribution 05415067029034 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 15415067029031 15415067029031 05415067029034 05415067029034 5415067029034
GMDN Terms# Term, Definition table Term Definition Percutaneous electrosurgical probe, denervation, monopolar, single-use A sterile, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 15 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool and dry place; avoid exposure to extreme temperatures.
Regulatory Flags# DUNS number 149818952 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 true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10884450452346 ViaVerte™ Merit Medical Systems, Inc. GXI 2026-05-19 07613327601121 OptaBlate STRYKER CORPORATION GXI 2025-05-27 07613327601169 OptaBlate STRYKER CORPORATION GXI 2025-05-27 10195327666354 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. GXI 2024-11-03 M661SST221505 Radiofrequency (RF) Needle Spectra Medical Devices, LLC GXI 2024-06-18 10195327493172 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. GXI 2024-01-07 10195327493189 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. GXI 2024-01-07 10195327493202 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. GXI 2024-01-07 20763000835631 Accurian MEDTRONIC SOFAMOR DANEK, INC. GXI 2023-09-25 20763000835648 Accurian MEDTRONIC SOFAMOR DANEK, INC. GXI 2023-09-25 20763000835655 Accurian MEDTRONIC SOFAMOR DANEK, INC. GXI 2023-09-25 10195327047030 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. GXI 2022-08-04 00193493000265 COOLIEF* Avanos Medical, Inc. GXI 2022-03-17 00193493000272 COOLIEF* Avanos Medical, Inc. GXI 2022-03-17 00193493000296 AVANOS* Avanos Medical, Inc. GXI 2022-03-12 00193493000302 AVANOS* Avanos Medical, Inc. GXI 2022-03-12 00193493000326 COOLIEF* Avanos Medical, Inc. GXI 2022-03-12 00193493985920 AVANOS* Avanos Medical, Inc. GXI 2022-03-12 00191506013097 SideKick™ 2 BOSTON SCIENTIFIC NEUROMODULATION CORPORATION GXI 2021-04-28 00191506013103 SideKick™ 2 BOSTON SCIENTIFIC NEUROMODULATION CORPORATION GXI 2021-04-28 00191506013110 SideKick™ 2 BOSTON SCIENTIFIC NEUROMODULATION CORPORATION GXI 2021-04-28 00191506013127 SideKick™ 2 BOSTON SCIENTIFIC NEUROMODULATION CORPORATION GXI 2021-04-28 00193493000159 AVANOS Avanos Medical, Inc. GXI 2021-03-11 00193493000166 AVANOS Avanos Medical, Inc. GXI 2021-03-11 00193493000173 AVANOS Avanos Medical, Inc. GXI 2021-03-11 00193493000197 AVANOS Avanos Medical, Inc. GXI 2021-03-11 00193493000203 AVANOS Avanos Medical, Inc. GXI 2021-03-11 00193493478804 AVANOS Avanos Medical, Inc. GXI 2021-03-11 00193493478811 AVANOS Avanos Medical, Inc. GXI 2021-03-11 00193493478828 AVANOS Avanos Medical, Inc. GXI 2021-03-11
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