EBA ONE EBA-586120

GUDID 08059386742068

CITIEFFE SRL

Orthopaedic bone screw (non-sliding)
Primary Device ID08059386742068
NIH Device Record Key224b34eb-2a9a-4e85-a2d6-7d82f9d978e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEBA ONE
Version Model NumberEba One locking cephalic screw ø10.5mm L120mm
Catalog NumberEBA-586120
Company DUNS431406875
Company NameCITIEFFE SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com
Phone+39051721850
Emailsupport@citieffe.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS108059386742068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

On-Brand Devices [EBA ONE]

08052990979974Nails extractor
08052990979967Cephalic screwdriver, XXL
08052990979950Allen T-screwdriver, 5mm XXL
08052990979943Trocar for stabilization wire, XXL
08052990979936Diaphyseal trocar, XXL
08052990979929Cephalic trocar, XXL
08052990979912Tissue protection sleeve, XXL
08052990979905Diaphyseal cannula, XXL
08052990979899Cephalic cannula, XXL
08052990979882Targeting device, XXL
08052990979875Tap for cephalic screw
08052990979844Cardanic screwdriver, 3.5mm
08052990979837Cephalic screwdriver
08052990979820Allen T-screwdriver, 5mm
08052990979813Cephalic screw ruler
08052990979806Trocar for stabilization wire
08052990979790Diaphyseal trocar
08052990979783Cephalic trocar
08052990979776Tissue protection sleeve
08052990979769Diaphyseal cannula
08052990979752Cephalic cannula
08052990979738Cannulated awl
08052990979721Targeting device, 130°
08052990979714Targeting device, 125°
08052990979707Targeting device, 120°
08052990979691Inserter
08052990979684Guide wire ø3x800mm (STERILE)
08052990979677Guide wire ø3x800mm
08052990979660Graduated drill bit, ø4mm XXL
08052990979653Graduated drill bit, ø4mm
08052990979646Cannulated reamer ø16mm, XXL
08052990979639Cannulated reamer ø16mm
08052990979622Cephalic drill, XXL
08052990979615Cephalic drill
08052990979516End cap 10mm
08052990979509End cap 5mm
08052990979493End cap 0mm
08052990979486Cortical screw ø5.2mm L110mm
08052990979479Cortical screw ø5.2mm L105mm
08052990979462Cortical screw ø5.2mm L100mm
08052990979455Cortical screw ø5.2mm L95mm
08052990979448Cortical screw ø5.2mm L90mm
08052990979431Cortical screw ø5.2mm L85mm
08052990979424Cortical screw ø5.2mm L80mm
08052990979417Cortical screw ø5.2mm L75mm
08052990979400Cortical screw ø5.2mm L70mm
08052990979394Cortical screw ø5.2mm L65mm
08052990979387Cortical screw ø5.2mm L60mm
08052990979370Cortical screw ø5.2mm L55mm
08052990979363Cortical screw ø5.2mm L50mm

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