EBA2 EBA-661046

GUDID 08032909623426

Kit composed of: - Right Nail ø10mm L460mm (1 pc); - Guide wire (1 pc). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136).

CITIEFFE SRL

Femur nail

• Primary Device ID: 08032909623426
• NIH Device Record Key: 38d82b55-c430-4d61-a0fd-b2bdb4ff94e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EBA2
• Version Model Number: Long nail ø10mm L460mm, right
• Catalog Number: EBA-661046
• 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: 460 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 460 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 460 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 460 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 460 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 460 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 460 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 460 Millimeter
• Outer Diameter: 10 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	08032909623426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131005

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: 2016-10-11

On-Brand Devices [EBA2]

• 08032909627837: Nail and screw ruler
• 08032909627646: Disposable scalpel ø8x10mm
• 08032909627738: Cannula
• 08032909627714: Tissue protection sleeve
• 08032909627684: Long nail instrument tray
• 08032909627677: Instrument set tray
• 08032909627080: End cap for femoral nail. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909629589: End cap for femoral nail. Lenght: Standard cap + 15 mm. Material: titanium alloy Ti6Al4V ELI (AS
• 08032909627103: Kit composed of: - Femoral nail L240mm (1 pc); - Guide wire (1 pc). Nail material: titanium allo
• 08032909627097: Kit composed of: - Femoral nail L180mm (1 pc); - Guide wire (1 pc). Nail material: titanium allo
• 08032909625819: Kit composed of: - Left Nail ø13mm L460mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625802: Kit composed of: - Left Nail ø13mm L440mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625796: Kit composed of: - Left Nail ø13mm L420mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625789: Kit composed of: - Left Nail ø13mm L400mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625772: Kit composed of: - Left Nail ø13mm L380mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625765: Kit composed of: - Left Nail ø13mm L360mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625758: Kit composed of: - Left Nail ø13mm L340mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625741: Kit composed of: - Left Nail ø13mm L320mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625734: Kit composed of: - Left Nail ø12mm L460mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625727: Kit composed of: - Left Nail ø12mm L440mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625710: Kit composed of: - Left Nail ø12mm L420mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625703: Kit composed of: - Left Nail ø12mm L400mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625697: Kit composed of: - Left Nail ø12mm L380mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625680: Kit composed of: - Left Nail ø12mm L360mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625673: Kit composed of: - Left Nail ø12mm L340mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625666: Kit composed of: - Left Nail ø12mm L320mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625659: Kit composed of: - Left Nail ø11mm L460mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625642: Kit composed of: - Left Nail ø11mm L440mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625635: Kit composed of: - Left Nail ø11mm L420mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625628: Kit composed of: - Left Nail ø11mm L400mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625611: Kit composed of: - Left Nail ø11mm L380mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625604: Kit composed of: - Left Nail ø11mm L360mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625598: Kit composed of: - Left Nail ø11mm L340mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625581: Kit composed of: - Left Nail ø11mm L320mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625574: Kit composed of: - Left Nail ø10mm L460mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625567: Kit composed of: - Left Nail ø10mm L440mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625550: Kit composed of: - Left Nail ø10mm L420mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625543: Kit composed of: - Left Nail ø10mm L400mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625536: Kit composed of: - Left Nail ø10mm L380mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625529: Kit composed of: - Left Nail ø10mm L360mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625512: Kit composed of: - Left Nail ø10mm L340mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625505: Kit composed of: - Left Nail ø10mm L320mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625499: Kit composed of: - Left Nail ø10mm L300mm (1 pc); - Guide wire (1 pc). Material of the nail: ti
• 08032909625482: Kit composed of: - Left Nail ø9mm L380mm (1 pc); - Guide wire (1 pc). Material of the nail: tit
• 08032909625475: Kit composed of: - Left Nail ø9mm L360mm (1 pc); - Guide wire (1 pc). Material of the nail: tit
• 08032909625468: Kit composed of: - Left Nail ø9mm L340mm (1 pc); - Guide wire (1 pc). Material of the nail: tit
• 08032909625451: Kit composed of: - Left Nail ø9mm L320mm (1 pc); - Guide wire (1 pc). Material of the nail: tit
• 08032909625444: Kit composed of: - Left Nail ø9mm L300mm (1 pc); - Guide wire (1 pc). Material of the nail: tit
• 08032909625437: Kit composed of: - Right Nail ø13mm L460mm (1 pc); - Guide wire (1 pc). Material of the nail: t
• 08032909625420: Kit composed of: - Right Nail ø13mm L440mm (1 pc); - Guide wire (1 pc). Material of the nail: t