FDA.reportPublic FDA data

SP-Tip

Primary DI
00810026180965
Brand
SP-Tip
Company
SONIQUENCE, LLC
Model
SASST-27
Catalog number
SASST-27
Device description
Assortment pack
Published
2022-01-18
Public version status
New
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
00810026180965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810026180965008100261809658100261809650810026180965

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/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 single-use device intended to be used in a sterile condition.

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
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26