FDA.reportPublic FDA data

ELOS INSTRUMENTS

Primary DI
08056693001932
Brand
ELOS INSTRUMENTS
Company
INTRAUMA SPA
Model
SE2.S001
Catalog number
SE2.S001
Device description
Sterile Guide Wires Set (3pcs)
Published
2023-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201147000Elos® Intramedullary Nailing SystemIntrauma S.P.A2021-07-19HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056693001932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056693001932080566930019328056693001932

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
387588051
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056693086397ELOS INSTRUMENTSSE256ASE256A2026-10-13
08056693086403ELOS INSTRUMENTSSE258ASE258A2026-10-13
08056693086410ELOS INSTRUMENTSSE259SE2592026-10-13
08056693001352ELOS200.0001200.00012022-09-12
08056693000126INTRAUMA SURGICAL INSTRUMENTS205S2052025-11-27
08056693001949WRISTAR MULTIAXKM1.9031KM1.90312025-11-27
08056693001956WRISTAR MULTIAXKM1.9032KM1.90322025-11-27
08056693001963WRISTAR MULTIAXKM1.9033KM1.90332025-11-27
08056693001970WRISTAR MULTIAXKM1.9034KM1.90342025-11-27
08056693001987WRISTAR MULTIAXKM1.9035KM1.90352025-11-27
08056693001994WRISTAR MULTIAXKM1.9036KM1.90362025-11-27
08056693002007WRISTAR MULTIAXKM1.9037KM1.90372025-11-27
08056693002014WRISTAR MULTIAXKM1.9038KM1.90382025-11-27
08056693002083MULTIAX SCREW120.2308120.23082025-11-27
08056693002090MULTIAX SCREW120.2310120.23102025-11-27
08056693002106MULTIAX SCREW120.2312120.23122025-11-27
08056693002113MULTIAX SCREW120.2314120.23142025-11-27
08056693002120MULTIAX SCREW120.2316120.23162025-11-27
08056693002137MULTIAX SCREW120.2318120.23182025-11-27
08056693002144MULTIAX SCREW120.2320120.23202025-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M97012000112300DynaNailMedshape, Inc.HSB2026-10-16
08056693086397ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086403ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086410ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
00817867021044PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021051PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021068PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021075PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021082PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021099PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021105PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021112PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021129PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021136PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021143PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021150PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021167PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021174PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021181PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021198PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021204PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021211PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021228PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021235PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021242PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021259PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021266PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021273PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021280PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021297PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01