FDA.reportPublic FDA data

Sp-Tip

Primary DI
00810026181054
Brand
Sp-Tip
Company
SONIQUENCE, LLC
Model
SST-B3
Catalog number
SST-B3
Device description
3mm ball, 3cm shaft length
Published
2021-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183611000Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC2019-05-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810026182020PackageGS125In Commercial Distribution
00810026181054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810026182020008100261820208100261820200810026182020
00810026181054008100261810548100261810540810026181054

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117308190
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810026183782SP-TipSST-MWSST-MW2025-07-18
00810026183652SP-TipSST-T10SST-T102023-10-06
00810026183690Soni-CervSST-SB3SST-SB32023-10-06
00810026183669SP-TipSST-T10SST-T102023-10-06
00810026183706Soni-CervSST-SB3SST-SB32023-10-06
00810026183775Bleph kitSBK-01SBK-012023-10-06
00810026180248Blepharoplasty kitSBK-01SBK-012022-04-11
00810026180972Reusable HandpieceSIEC-3FHPB/NSSIEC-3FHPB/NS2022-12-30
00810026181535RF GeneratorIEC6-SESP120IEC6-SESP1202020-05-19
00810026181542RF GeneratorIEC6-IESP170IEC6-IESP1702020-05-19
00810026181559RF GeneratorIEC6-IENSP170IEC6-IENSP1702020-05-19
00810026181566RF GeneratorIEC6-SESP170IEC6-SESP1702020-05-19
00810026181573RF GeneratorIEC6-SENSP170IEC6-SENSP1702020-05-19
00810026181580RF GeneratorIEC6-IESU120IEC6-IESU1202020-05-19
00810026181597RF GeneratorIEC6-IENSU120IEC6-IENSU1202020-05-19
00810026181603RF GeneratorIEC6-SENSU120IEC6-SENSU1202020-05-19
00810026181610RF GeneratorIEC6-SESU120IEC6-SESU1202020-05-19
00810026181627RF GeneratorIEC6-IESU170IEC6-IESU1702020-05-19
00810026181634RF GeneratorIEC6-IENSU170IEC6-IENSU1702020-05-19
00810026181641RF GeneratorIEC6-SESU170IEC6-SESU1702020-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03