FDA.reportPublic FDA data

ELMED

Primary DI
00842180137004
Brand
ELMED
Company
ELMED INCORPORATED
Model
5760
Catalog number
5760
Device description
ELMED ESU 400 DIGITAL - GENERATION 2 ELECTROSURGICAL UNIT, FEATURING: MONOPOLAR AND BIPOLAR CUT AND COAGULATION, DIGITAL TOUCH SCREEN SELECTION AND MULTI-SCREEN DISPLAY, SMART-O-MATIC AUTOMATIC OUTPUT COMPENSATION FOR ALL ELECTRODES AND TISSUE CONDITION, SAFETY PATIENT RETURN ELECTRODE CIRCUIT.
Published
2020-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00842180137004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180137004008421801370048421801370040842180137004

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884521766662ValleylabCovidien LPBWA2021-04-08
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
10885403007026V. MuellerCAREFUSION 2200, INCBWA2016-10-11
10885403007033V. MuellerCAREFUSION 2200, INCBWA2016-10-11
10885403007040V. MuellerCAREFUSION 2200, INCBWA2016-10-11