FDA.reportPublic FDA data

ELMED

Primary DI
00842180166059
Brand
ELMED
Company
ELMED INCORPORATED
Model
31845-01
Catalog number
31845-01
Device description
Flexible Monopolar Coagulation Electrode, Ball Electrode
Published
2023-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K915731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915731000ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITALElmed, Inc.1992-11-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180166059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180166059008421801660598421801660590842180166059

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It 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/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842180192515ELMEDST180831ST1808312024-04-10
00842180167766ELMED18-083118-08312023-04-21
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006143Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006150Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006167Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006174Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006198Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006211Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02