FDA.reportPublic FDA data

Eleganz IM Threaded Nail

Primary DI
00810190981337
Brand
Eleganz IM Threaded Nail
Company
Dev4
Model
MC-4535
Device description
4.5 Threaded Nail 35mm
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810190981337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810190981337008101909813378101909813370810190981337

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119211016
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810190981023Eleganz IM Threaded NailMC-25112026-04-23
00810190981030Eleganz IM Threaded NailMC-25132026-04-23
00810190981047Eleganz IM Threaded NailMC-25152026-04-23
00810190981054Eleganz IM Threaded NailMC-25172026-04-23
00810190981061Eleganz IM Threaded NailMC-25192026-04-23
00810190981078Eleganz IM Threaded NailMC-25212026-04-23
00810190981085Eleganz IM Threaded NailMC-25232026-04-23
00810190981092Eleganz IM Threaded NailMC-25252026-04-23
00810190981108Eleganz IM Threaded NailMC-25302026-04-23
00810190981115Eleganz IM Threaded NailMC-25352026-04-23
00810190981122Eleganz IM Threaded NailMC-25402026-04-23
00810190981139Eleganz IM Threaded NailMC-25452026-04-23
00810190981146Eleganz IM Threaded NailMC-25502026-04-23
00810190981153Eleganz IM Threaded NailMC-25552026-04-23
00810190981160Eleganz IM Threaded NailMC-25602026-04-23
00810190981177Eleganz IM Threaded NailMC-25652026-04-23
00810190981184Eleganz IM Threaded NailMC-25702026-04-23
00810190981191Eleganz IM Threaded NailMC-25752026-04-23
00810190981207Eleganz IM Threaded NailMC-35252026-04-23
00810190981214Eleganz IM Threaded NailMC-35302026-04-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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