FDA.reportPublic FDA data

seemann

Primary DI
26939029816652
Brand
seemann
Company
Modern Medical Equipment MFG. Ltd.
Model
ST-99-512
Device description
Open-surgery electrosurgical electrode, monopolar, single-use
Published
2017-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16939029816655PackageGS150In Commercial Distribution
26939029816652PackageGS120In Commercial Distribution
06939029816658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693902981665516939029816655
2693902981665226939029816652
06939029816658069390298166586939029816658

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
527812392
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939029817228OlympusWA98600A2018-04-11
06939029817235OlympusWA98700A2018-04-11
06939029815132OlympusET8652021-05-30
06939029817303OlympusPD650WA98225B2021-05-30
06939029817372OlympusPD735WA98216R2021-05-30
06939029817389OlympusPD635WA98215F2021-05-30
06939029817396OlympusPD635WA98225F2021-05-30
06939029817402OlympusPD635WA98216F2021-05-30
06939029817419OlympusPD635WA98226F2021-05-30
06939029817525OlympusMH432WA98400A2021-05-30
06939029818263OlympusET8652021-05-08
06939029818270OlympusET4562021-05-08
06939029818287OlympusET8652021-05-08
06939029818294OlympusEF4562021-05-08
06939029818317OlympusPD7352021-05-08
06939029818331OlympusPD6502021-05-08
06939029818355OlympusPD7352021-05-08
06939029818195OlympusEF4402021-05-07
06939029818201OlympusET8652021-05-07
06939029818218OlympusEF4412021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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