FDA.reportPublic FDA data

ELRA Electrode

Primary DI
08809306762368
Brand
ELRA Electrode
Company
STARMED CO.,LTD
Model
7-2B22S
Device description
The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators.The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.
Published
2019-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809306762365PackageGS15In Commercial Distribution
28809306762362PackageGS110In Commercial Distribution
08809306762368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880930676236518809306762365
2880930676236228809306762362
08809306762368088093067623688809306762368

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Shaft Length40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82318163546inquiry@starmed4u.com

Regulatory Flags#

DUNS number
694699723
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
08809306769251TS-RF GeneratorSTS102025-12-01
08809306769244VVR GeneratorVVR102024-09-30
08809306764010VENISTAR7-VENI007090N2024-08-29
08809306764874VENISTAR3-VENI003090N2024-08-29
08809306767868VENISTAR3-VENI0030N2024-08-29
08809306767875VENISTAR7-VENI0070N2024-08-29
18809306764017VENISTAR7-VENI007090N2024-08-29
18809306764871VENISTAR3-VENI003090N2024-08-29
18809306767865VENISTAR3-VENI0030N2024-08-29
18809306767872VENISTAR7-VENI0070N2024-08-29
08809922260637ELRA Electrode7-2B11L2024-08-28
18809922260634ELRA Electrode7-2B11L2024-08-28
08809922260620ELRA Electrode7-2B11S2023-11-24
08809922260644ELRA Electrode7-2B22S2023-11-24
08809922260651ELRA Electrode7-2B22L2023-11-24
08809922260668ELRA Electrode7-4B18S2023-11-24
08809922260675ELRA Electrode7-4B18L2023-11-24
08809922260682ELRA Electrode7-4B33S2023-11-24
08809922260699ELRA Electrode7-4B33L2023-11-24
08809306760012star RF Electrode17-15s20F17-15s20F2018-03-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
04545499074423SB Knife Jr2SB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
04545499074430SB Knife Jr2 /Long typeSB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
00827002613515SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002613522SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002597501Tesla BicordCOOK INCORPORATEDKNS2025-07-11
00724995226732Padlock ClipUS EndoscopyKNS2024-10-31
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
04055207007822NARichard Wolf GmbHKNS2024-08-19
04055207008393NARichard Wolf GmbHKNS2024-08-19
04055207058985NARichard Wolf GmbHKNS2024-08-19
20653405051555APOLLO3Conmed CorporationKNS2024-07-22
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