FDA.reportPublic FDA data

NA

Primary DI
00813250011814
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
SC-1
Device description
Storage and Carrying Case for 1A/1B
Published
2017-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00813250011814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813250011814008132500118148132500118140813250011814

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824951958
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506070564NANM-7174M365NM717402026-06-08
00191506070595NADB-7174M365DB717402026-06-08
08714729789550Linear™ 3-4SC-2352-502015-12-15
08714729789574Linear™ 3-6SC-2366-502015-12-15
08714729789659Linear™ 3-6SC-2366-302015-12-14
08714729896098NADB-42522017-12-15
08714729896104NADB-42542017-12-15
08714729896111NADB-4100A2017-12-15
08714729931751NADB-43202017-12-12
08714729965848Vercise™DB-64125-US2017-12-12
08714729121466Precision™SC-43002015-11-09
08714729121473Precision™SC-43052015-11-09
08714729121480Precision™SC-43102015-11-09
08714729767572Precision ™SC-42302015-11-09
08714729767626Precision™SC-43062015-11-09
08714729767756Precision™SC-43012015-11-09
08714729767763Precision™SC-43112015-11-09
08714729888734Precision™SC-9218-152015-12-14
08714729888758Precision™SC-9218-552015-12-14
08714729893271Precision™SC-9208-152015-12-14

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