FDA.reportPublic FDA data

ELMED

Primary DI
00842180135208
Brand
ELMED
Company
ELMED INCORPORATED
Model
5531-08*
Catalog number
5531-08*
Device description
"ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, CUSHING BAYONET W/IRRIGATION, 8 3/4"" (22CM) INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)"
Published
2018-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BWAUnit, Electrosurgical Andcoagulation, With Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWAUnit, Electrosurgical And Coagulation, With AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180135208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180135208008421801352088421801352080842180135208

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091568ELMED INCORPORATED115 515/715115 515/7152026-06-08
00842180148864ELMED INCORPORATED232 412232 4122026-06-08
00198506091414ELMED INCORPORATED52002-92552002-9252026-06-05
00198506091421ELMED INCORPORATED52002-92952002-9292026-06-05
00198506091438ELMED INCORPORATED52002-93352002-9332026-06-05
00198506091445ELMED INCORPORATED24-1951524-195152026-06-05
00198506091452ELMED INCORPORATED51290-30STR51290-30STR2026-06-05
00198506091469ELMED INCORPORATED51290-12STR51290-12STR2026-06-05
00198506091155ELMED INCORPORATED37-5006-10ST37-5006-10ST2026-06-03
00198506091162ELMED INCORPORATED37-1010137-101012026-06-03
00198506091179ELMED INCORPORATEDSTE287850STE2878502026-06-03
00198506091186ELMED INCORPORATED37-013837-01382026-06-03
00198506091193ELMED INCORPORATED37-013937-01392026-06-03
00198506091209ELMED INCORPORATEDSTE1121040STE11210402026-06-03
00198506091216ELMED INCORPORATEDSTE3321924STE33219242026-06-03
00198506091223ELMED INCORPORATED42-242042-24202026-06-03
00198506091230ELMED INCORPORATEDSM13443-21-CRSM13443-21-CR2026-06-03
00198506091247ELMED INCORPORATED52125-7952125-792026-06-03
00198506091254ELMED INCORPORATED52105-61-0552105-61-052026-06-03
00198506091261ELMED INCORPORATED5990M255990M252026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089473ELMED INCORPORATEDELMED INCORPORATEDBWA2026-04-02
00198506088889ELMED INCORPORATEDELMED INCORPORATEDBWA2026-03-03
00198506084294ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-29
00198506053887ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-24
00198506054242ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-17
00198506053955ELMED INCORPORATEDELMED INCORPORATEDBWA2025-05-09
00198506064494ELMED INCORPORATEDELMED INCORPORATEDBWA2024-10-22
00198506064883ELMED INCORPORATEDELMED INCORPORATEDBWA2024-10-22
00198506061875ELMED INCORPORATEDELMED INCORPORATEDBWA2024-09-25
00198506060717ELMED INCORPORATEDELMED INCORPORATEDBWA2024-08-26
00842180175884ELMEDELMED INCORPORATEDBWA2023-08-11
00842180152908ELMEDELMED INCORPORATEDBWA2023-01-10
00842180156760ELMEDELMED INCORPORATEDBWA2023-01-09
10884521766662ValleylabCovidien LPBWA2021-04-08
00842180137004ELMEDELMED INCORPORATEDBWA2020-08-18
00842180136915ELMEDELMED INCORPORATEDBWA2020-06-17
B382SD84850Surgical DirectSurgical Direct, Inc.BWA2020-04-29
00842180136724ELMEDELMED INCORPORATEDBWA2020-03-05
00842180136519ELMEDELMED INCORPORATEDBWA2019-11-06
00842180136472ELMEDELMED INCORPORATEDBWA2019-10-23
00842180135888ELMEDELMED INCORPORATEDBWA2019-04-09
00842180135833ELMEDELMED INCORPORATEDBWA2019-03-06
00842180135178ELMEDELMED INCORPORATEDBWA2018-08-17
00842180111974ELMEDELMED INCORPORATEDBWA2018-03-07
00842180107946ELMEDELMED INCORPORATEDBWA2017-04-25
00842180106796ELMEDELMED INCORPORATEDBWA2016-12-28
00842180106802ELMEDELMED INCORPORATEDBWA2016-12-28
00842180106192ELMEDELMED INCORPORATEDBWA2016-10-25
00842180106208ELMEDELMED INCORPORATEDBWA2016-10-25
00842180106215ELMEDELMED INCORPORATEDBWA2016-10-25