FDA.reportPublic FDA data

SP-Tip

Primary DI
00810026181030
Brand
SP-Tip
Company
SONIQUENCE, LLC
Model
SST-L3
Catalog number
SST-L3
Device description
3mm loop, 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
00810026182006PackageGS125In Commercial Distribution
00810026181030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810026182006008100261820068100261820060810026182006
00810026181030008100261810308100261810300810026181030

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

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
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16