FDA.reportPublic FDA data

#108H Electrode

Primary DI
00841494100384
Brand
#108H Electrode
Company
Cynosure, LLC
Model
T108HB
Catalog number
T108HB
Device description
#108H Electrode
Published
2016-09-19
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
JOSElectrode, electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOSElectrode, ElectrosurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494100384PrimaryGS10
10841494100381Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494100384008414941003848414941003840841494100384
1084149410038110841494100381

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24
00841494106980PicoSure 532 Delivery System100-7012-5322017-07-24
00841494106997PicoSure 1064 Delivery System100-7012-1642017-07-24
00841494107246Refusrbished, Handpiece, 1064, PicoR100-7012-0792017-07-24
00841494107253Refusrbished, Handpiece, 532, PicoR100-7012-0762017-07-24
00841494104214PERF-GRIDEPG107EPG1072016-09-21
00841494104689SPLINT GRID NYLON MESH ROLLESG118ESG1182016-09-21
00841494104696SPLINT MESH STAINLESS STEEL MESH ROLLESG117ESG1172016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809295141007BIG-TIP™ RF Medical Co.,Ltd.JOS2025-09-05
08800142925092THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925108THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925115THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925122THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
04050147022751ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022768ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022775ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022782ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023543ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023550ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023567ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023574ErbeErbe Elektromedizin GmbHJOS2025-01-21
00821925008083BovieGyrus ACMI, LLCJOS2024-07-25
00821925008458BovieGyrus ACMI, LLCJOS2024-07-25
00845854030632CONMEDConmed CorporationJOS2023-12-05
08800142919206THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919213THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919220THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08809295147382V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147399V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147405V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147412V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147429V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147436V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147443V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147450V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147467V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147474V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147481V-TipRF Medical Co.,Ltd.JOS2023-10-24