FDA.report

ELOS

Primary DI
08056693001024
Brand
ELOS
Company
INTRAUMA SPA
Model
200.4001
Catalog number
200.4001
Device description
Long Nail, LEFT
Published
2023-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions

SubmissionSupplement
K201147000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K201147000Elos® Intramedullary Nailing SystemIntrauma S.P.A2021-07-19HSB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08056693001024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08056693001024080566930010248056693001024

GMDN Terms

TermDefinition
Femur intramedullary nailA rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length400Millimeter
Outer Diameter10Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
387588051
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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08056693001956WRISTAR MULTIAXKM1.9032KM1.90322025-11-27
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08056693001970WRISTAR MULTIAXKM1.9034KM1.90342025-11-27
08056693001987WRISTAR MULTIAXKM1.9035KM1.90352025-11-27
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08056693002007WRISTAR MULTIAXKM1.9037KM1.90372025-11-27
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08056693002120MULTIAX SCREW120.2316120.23162025-11-27
08056693002137MULTIAX SCREW120.2318120.23182025-11-27
08056693002144MULTIAX SCREW120.2320120.23202025-11-27
08056693002151MULTIAX SCREW120.2322120.23222025-11-27
08056693002168MULTIAX SCREW120.2324120.23242025-11-27
08056693002175MULTIAX SCREW120.2326120.23262025-11-27
08056693002182MULTIAX SCREW120.2328120.23282025-11-27

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