FDA.reportPublic FDA data

Meduloc Intramedullary Fracture Fixation (IFF) System

Primary DI
00810184540472
Brand
Meduloc Intramedullary Fracture Fixation (IFF) System
Company
MEDULOC, LLC
Model
90-IFF-190025
Catalog number
90-IFF-190025
Device description
Removal Trephine (2.5)
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
LXEDoppler, Fetal, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXEDoppler, Fetal, UltrasoundObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810184540472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184540472008101845404728101845404720810184540472

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
111186753
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810184540007Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20001590-IFF-2000152026-01-14
00810184540014Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20051590-IFF-2005152026-01-14
00810184540021Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20002090-IFF-2000202026-01-14
00810184540038Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20052090-IFF-2005202026-01-14
00810184540045Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20002590-IFF-2000252026-01-14
00810184540052Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20052590-IFF-2005252026-01-14
00810184540069Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20003090-IFF-2000302026-01-14
00810184540076Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20053090-IFF-2005302026-01-14
00810184540083Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20003590-IFF-2000352026-01-14
00810184540090Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20053590-IFF-2005352026-01-14
00810184540106Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15001590-IFF-1500152026-01-14
00810184540113Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15002090-IFF-1500202026-01-14
00810184540120Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15002590-IFF-1500252026-01-14
00810184540137Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15003090-IFF-1500302026-01-14
00810184540144Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15003590-IFF-1500352026-01-14
00810184540151Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16001590-IFF-1600152026-01-14
00810184540168Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16002090-IFF-1600202026-01-14
00810184540175Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16002590-IFF-1600252026-01-14
00810184540182Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16003090-IFF-1600302026-01-14
00810184540199Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16003590-IFF-1600352026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662200012954NOVAESOC ETUDES RECHERCHES FABRICATIONLXE2022-12-09
00852785008258DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008265DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008272DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008302DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008319DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008326DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008333DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008364DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008371DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008388DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008395DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008425DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008432DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008449DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008456DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008487DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008494DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008531DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008548DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008555DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008562DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008807DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008814DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008821DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008838DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008876DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008883DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008890DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008906DigiDopNEWMAN MEDICAL LLCLXE2021-06-25