FDA.reportPublic FDA data

Swaroplate

Primary DI
15060441919196
Brand
Swaroplate
Company
NISSHA MEDICAL TECHNOLOGIES LTD
Model
1201H
Catalog number
6000782N
Device description
Neutral Electrode
Published
2021-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K203494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203494000Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd.2021-02-23GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35060441919190PackageGS125In Commercial Distribution
55060441919194PackageGS1300In Commercial Distribution
15060441919196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3506044191919035060441919190
5506044191919455060441919194
1506044191919615060441919196

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
671405566
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060441917826swaromed10366000045C2026-04-07
15060441918212swaromed40366000578C2026-04-07
15060441918229swaromed40666000581C2026-04-07
15060441918236swaromed40096000582C2026-04-07
15060441918250swaromed40606000588C2026-04-07
15060441918755swaromed40406001237C2026-04-07
15060842920197N/AGX1-1285H2025-06-18
15060842920210N/AGX1-1280H2025-06-18
35060842920191N/AGX1-1285H2025-06-18
35060842920214N/AGX1-1280H2025-06-18
15060842920234Corpuls1019CO19101.192025-02-18
35060842920238Corpuls1019CO19101.192025-02-18
15060842920142DrägerFW50DR7000018722024-03-01
15060842920159DrägerFW32PDR7000018732024-03-01
35060842920146DrägerFW50DR7000018722024-03-01
35060842920153DrägerFW32PDR7000018732024-03-01
15060441915105VERMEDF7957W4011003C2018-01-11
15060441915174VERMEDF79504010989C2018-01-08
15060441915181VERMEDF79514010990C2018-01-08
15060441915198VERMEDF79524010991C2018-01-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
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07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10