FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506089817
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
52-5686
Catalog number
52-5686
Device description
ELMED ENDO-TEST INSTRUMENT INSULATION TESTER WITH MONOPOLAR & BIPOLAR CABLE TEST CIRCUIT, COMPLETE WITH AUTOCLAVABLE TEST ELECTRODES, CABLES & SPONGES AND INCLUDES OPERATION INSTRUCTION POSTER AND MANUAL.
Published
2026-04-02
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181173000ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated2019-03-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506089817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506089817001985060898171985060898170198506089817

GMDN Terms#

Term, Definition table
TermDefinition
Leakage current testerA battery-powered instrument intended to be used to perform either alternating current (AC) or direct current (DC) leakage testing on electronic equipment. It typically includes an Amperimeter that can measure in a range of milliamperes/amperes and appropriate accessories (e.g., leads, clips) to perform the measurements. The device may determine leakage current in medical device chassis and patient leads, preventing patient risks (e.g., heart fibrillation). Some devices include visual and/or sound alarms that operate when a pre-set value is reached.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091612ELMED INCORPORATED24129-10B-KW24129-10B-KW2026-06-24
00198506091629ELMED INCORPORATED24129-08B-KW24129-08B-KW2026-06-24
00198506091506ELMED INCORPORATED53020-7853020-782026-06-10
00198506091513ELMED INCORPORATEDSTE3212113ISTE3212113I2026-06-10
00198506091520ELMED INCORPORATEDSTE3212313ISTE3212313I2026-06-10
00198506091537ELMED INCORPORATED32007-1532007-152026-06-10
00198506091544ELMED INCORPORATED32006-1532006-152026-06-10
00198506091551ELMED INCORPORATED23-2503LH23-2503LH2026-06-10
00198506091575ELMED INCORPORATED23-6020-1323-6020-132026-06-10
00198506091582ELMED INCORPORATED13579-2113579-212026-06-10
00198506044366ELMEDST52732404EST52732404E2026-06-09
00198506091278ELMED INCORPORATED55013-10A55013-10A2026-06-09
00198506091285ELMED INCORPORATED12-53785-042T12-53785-042T2026-06-09
00198506091292ELMED INCORPORATEDSS22-5200-09ASS22-5200-09A2026-06-09
00198506091308ELMED INCORPORATEDSS22-5200-09FSS22-5200-09F2026-06-09
00198506091315ELMED INCORPORATEDSTE379670STE3796702026-06-09
00198506091322ELMED INCORPORATEDSTE379675STE3796752026-06-09
00198506091339ELMED INCORPORATEDSTESM150526JC08ISTESM150526JC08I2026-06-09
00198506091346ELMED INCORPORATEDSTE4570910STE45709102026-06-09
00198506091353ELMED INCORPORATEDSTE239935STE2399352026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09