FDA.reportPublic FDA data

ELMED

Primary DI
00842180156760
Brand
ELMED
Company
ELMED INCORPORATED
Model
5970M
Catalog number
5970M
Device description
"DENNIS BIPOLAR SUBMUCOSAL TURBINATE PROBE ""M"""
Published
2023-01-09
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
00842180156760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180156760008421801567608421801567600842180156760

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
00198506056529ELMED INCORPORATEDSTT9920FSANSTT9920FSAN2026-10-16
00198506096075ELMED INCORPORATEDSTT9931FSANTSTT9931FSANT2026-10-16
00198506096082ELMED INCORPORATEDSTT9924FSANSTT9924FSAN2026-10-16
00198506096099ELMED INCORPORATEDST9932FSANTSTT9932FSANT2026-10-16
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09
00198506095900ELMED INCORPORATEDST7141016ST71410162026-10-09
00198506095917ELMED INCORPORATEDST7141017ST71410172026-10-09

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
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
00842180135208ELMEDELMED INCORPORATEDBWA2018-10-01
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