FDA.reportPublic FDA data

Swaroplate

Primary DI
15060441919417
Brand
Swaroplate
Company
NISSHA MEDICAL TECHNOLOGIES LTD
Model
1226H
Catalog number
6000806N
Device description
Neutral Electrode
Published
2021-04-29
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
35060441919411PackageGS150In Commercial Distribution
55060441919415PackageGS1600In Commercial Distribution
15060441919417PrimaryGS10
05060441919410Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3506044191941135060441919411
5506044191941555060441919415
1506044191941715060441919417
05060441919410050604419194105060441919410

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
5
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28