FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506089589
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
23-J0260E
Catalog number
23-J0260E
Device description
Cerclage Wire & Button, 26 GA, 10M
Published
2026-03-13
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
LHXTrousers, Anti-Shock

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506089589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506089589001985060895891985060895890198506089589

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, reusableA collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. 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
Premarket exempt
true
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
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
00198506091360ELMED INCORPORATED37350-64C137350-64C12026-06-09
00198506091377ELMED INCORPORATEDS37520-64C1S37520-64C12026-06-09
00198506091384ELMED INCORPORATED37520-06C137520-06C12026-06-09
00198506091391ELMED INCORPORATEDS37520-06C1S37520-06C12026-06-09
00198506091407ELMED INCORPORATEDSTE122857STE1228572026-06-09
00198506091476ELMED INCORPORATED12-36-1812-36-182026-06-09
00198506091483ELMED INCORPORATED51-4080-0851-4080-082026-06-09
00198506091490ELMED INCORPORATEDSTE321202EVSTE321202EV2026-06-09
00198506091568ELMED INCORPORATED115 515/715115 515/7152026-06-08
00842180148864ELMED INCORPORATED232 412232 4122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089596ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00885556919620R3Smith & Nephew, Inc.LHX2024-11-06
00885556919613R3Smith & Nephew, Inc.LHX2024-11-04
00191083047300AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047317AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047324AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047331AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047348AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047355AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047362AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047379AlloWedgeRti Surgical, Inc.LHX2024-10-14
00840343722876GEN2SURGIX MEDICAL LLCLHX2024-06-28
08800017205267LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
08800068981486LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
00840343720537GEN2SURGIX MEDICAL LLCLHX2023-12-15
00840343720957GEN2SURGIX MEDICAL LLCLHX2023-12-15
10889981321390SpecialsSeaspine Orthopedics CorporationLHX2023-12-06
00840343719326Gen2SURGIX MEDICAL LLCLHX2023-11-14
00840343719364Gen2SURGIX MEDICAL LLCLHX2023-11-14
00885556910757LegionSmith & Nephew, Inc.LHX2023-09-06
00840019967655Reform® Ti CT Modular MIS Pedicle Screw SystemPRECISION SPINE, INC.LHX2023-08-07
00885556832417Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LHX2023-08-02
10889981308315SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308322SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308339SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308346SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308353SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308438SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
00850005827337GENESIS AWL/TAPPERGenesis Biologics, Inc.LHX2023-03-16
00885556850794Cadence Total Ankle SystemSmith & Nephew, Inc.LHX2023-02-02