FDA.reportPublic FDA data

BONSS

Primary DI
06927155387296
Brand
BONSS
Company
Jiangsu Bonss Medical Technology Co., Ltd.
Model
BC304D
Published
2024-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K221743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221743000Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical ElectrodesJiangsu Bonss Medical Technology Co., Ltd.2023-09-07GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06927155387296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06927155387296069271553872966927155387296

GMDN Terms#

Term, Definition table
TermDefinition
Electrolytic-plasma electrosurgical systemAn assembly of devices intended to use radio-frequency (RF) alternating current in a bipolar configuration to excite electrolytes within a solution (typically saline) to create a focused, charged plasma sphere for cutting and coagulation of soft tissues during an endoscopic or open surgical procedure. The assembly includes a mains electricity (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and bipolar electrodes to apply the energy to the surgical site. It is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system) and is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543429834
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06927155387067BONSSBC402D2024-11-20
06927155387098BONSSBC4032024-11-20
06927155387135BONSSAC403E2024-11-20
06927155387142BONSSBC403E2024-11-20
06927155387159BONSSMC403E2024-11-20
06927155387173BONSSBC3042024-11-20
06927155387197BONSSBC304B2024-11-20
06927155387227BONSSBC3052024-11-20
06927155387289BONSSAC304D2024-11-20
06927155387302BONSSMC304D2024-11-20
06927155387319BONSSAC304E2024-11-20
06927155387326BONSSBC304E2024-11-20
06927155387333BONSSMC304E2024-11-20
06927155386916BONSSAC4012024-11-02
06927155386923BONSSMC4012024-11-02
06927155386930BONSSAC401A2024-11-02
06927155386947BONSSMC401B2024-11-02
06927155386954BONSSBC4012024-11-02
06927155386961BONSSAC4022024-11-02
06927155386978BONSSBC4022024-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693294MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693379MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693386MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693393MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693430MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693454MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693461MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693478MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693485MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693492MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693522MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693553MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693560MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10