ENDOVIS B.A. EBA-1950

GUDID 08032909620593

Kit composed of: - Femoral nail L400mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail material: titanium alloy Ti6Al4V ELI (ASTM F136).

CITIEFFE SRL

Femur nail

• Primary Device ID: 08032909620593
• NIH Device Record Key: f11ff6e2-6932-44d7-a621-4f674214e2f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOVIS B.A.
• Version Model Number: Long nail L400mm, left
• Catalog Number: EBA-1950
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter
• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter
• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter
• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter
• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter
• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter
• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter
• Device Size Text, specify: 0
• Length: 400 Millimeter
• Outer Diameter: 10.2 Millimeter
• Outer Diameter: 14.4 Millimeter

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08032909620593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113387

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-08
• Device Publish Date: 2015-10-21

On-Brand Devices [ENDOVIS B.A.]

• 08032909620326: Nails extractor
• 08032909625871: Screw length ruler
• 08032909620548: Cannula with handle
• 08032909620371: ø10mm cannula
• 08032909620357: Soft tissue protection sleeve
• 08032909620562: Medium and long nail instrument tray
• 08032909620470: Instrument tray for standard nail
• 08032909625826: End cap for femoral nail. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620395: Chuck for ø3mm wires
• 08032909620319: Cannulated awl
• 08032909620593: Kit composed of: - Femoral nail L400mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909620586: Kit composed of: - Femoral nail L400mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909620067: Kit composed of: - Femoral nail L360mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909620050: Kit composed of: - Femoral nail L360mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909620043: Kit composed of: - Femoral nail L320mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909620036: Kit composed of: - Femoral nail L320mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909620029: Kit composed of: - Femoral nail L240mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909620012: Kit composed of: - Femoral nail L195mm (1 pc); - Guide wire (1 pc); - End cap (1 pc). Nail mater
• 08032909625864: Guide wire (sterile)
• 08032909620340: Guide wire
• 08032909620654: Cortical screw ø5mm L80mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620647: Cortical screw ø5mm L75mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620630: Cortical screw ø5mm L70mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620623: Cortical screw ø5mm L65mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620616: Cortical screw ø5mm L60mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620609: Cortical screw ø5mm L55mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620210: Cortical screw ø5mm L50mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620203: Cortical screw ø5mm L45mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620197: Cortical screw ø5mm L40mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620180: Cortical screw ø5mm L35mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620173: Cortical screw ø5mm L30mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620166: Cephalic screw ø7.5mm L110mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620159: Cephalic screw ø7.5mm L105mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620142: Cephalic screw ø7.5mm L100mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620135: Cephalic screw ø7.5mm L95mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620128: Cephalic screw ø7.5mm L90mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620111: Cephalic screw ø7.5mm L85mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620104: Cephalic screw ø7.5mm L80mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620098: Cephalic screw ø7.5mm L75mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909620081: Cephalic screw ø7.5mm L70mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).