EBA ONE EBA-5233

GUDID 08059386741108

CITIEFFE SRL

Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use Medical ruler, single-use

• Primary Device ID: 08059386741108
• NIH Device Record Key: f59a0cca-348e-4617-9705-bd4cd41eeef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EBA ONE
• Version Model Number: Nails ruler kit with wire ø2,5x800mm
• Catalog Number: EBA-5233
• Company DUNS: 431406875
• Company Name: CITIEFFE SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com
• Phone: +39051721850
• Email: support@citieffe.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08059386741108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183666

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-27
• Device Publish Date: 2024-03-19

On-Brand Devices [EBA ONE]

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