ESTREMO DT312395

GUDID 08052990975402

CITIEFFE SRL

Femur nail

• Primary Device ID: 08052990975402
• NIH Device Record Key: 58739aec-ae3e-456e-9c4b-2932734d6b11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESTREMO
• Version Model Number: ESTREMO nail ø12x395mm
• Catalog Number: DT312395
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	08052990975402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181540

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: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2019-02-07

On-Brand Devices [ESTREMO]

• 08052990979523: Extractor, threaded M8x1
• 08052990976423: Slotted hammer
• 08052990976188: Kirschner wire, trocar tip ø3x350mm
• 08051739535372: Kirschner wire, trocar tip ø3x350mm
• 08051739535365: Graduated drill bit, ø4mm
• 08051739535358: Drill bit, ø4mm
• 08052990976416: Screws depth gauge
• 08052990976355: Nails ruler, wire 800mm
• 08052990976348: Template nails length
• 08052990976331: Screws ruler
• 08051739531602: Nails ruler kit with wire 1000mm
• 08051739531596: Nails ruler kit with wire 800mm
• 08051739535341: Guide wire with olive ø3x800mm
• 08051739535631: ESTREMO locking end cap, 10mm
• 08051739535624: ESTREMO locking end cap, 5mm
• 08052990976300: Cannula with handle
• 08052990976294: Cannula
• 08052990976393: Screws depth gauge
• 08051739536386: Compaction device
• 08051739536522: Drill bit, ø4x350mm (STERILE)
• 08051739536416: Drill bit, ø4x110mm (STERILE)
• 08052990976362: ESTREMO guide
• 08052990976560: ESTREMO instrument box, empty
• 08051739535877: ESTREMO instrument set tray, 3 empty
• 08051739535860: ESTREMO instrument set tray, 2 empty
• 08052990974634: ESTREMO locking end cap
• 08052990974627: ESTREMO end cap, 10mm
• 08052990974610: ESTREMO end cap, 5mm
• 08052990974603: ESTREMO end cap, standard
• 08052990979851: Chuck for ø3mm wires
• 08051739535815: Impaction bolt, cannulated
• 08052990976287: Cannulated awl
• 08052990975624: ESTREMO nail ø13x470mm
• 08052990975617: ESTREMO nail ø13x455mm
• 08052990975600: ESTREMO nail ø13x440mm
• 08052990975594: ESTREMO nail ø13x425mm
• 08052990975587: ESTREMO nail ø13x410mm
• 08052990975570: ESTREMO nail ø13x395mm
• 08052990975563: ESTREMO nail ø13x380mm
• 08052990975556: ESTREMO nail ø13x365mm
• 08052990975549: ESTREMO nail ø13x350mm
• 08052990975532: ESTREMO nail ø13x335mm
• 08052990975525: ESTREMO nail ø13x320mm
• 08052990975518: ESTREMO nail ø13x305mm
• 08052990975501: ESTREMO nail ø13x290mm
• 08052990975495: ESTREMO nail ø13x275mm
• 08052990975488: ESTREMO nail ø13x260mm
• 08052990975457: ESTREMO nail ø12x470mm
• 08052990975440: ESTREMO nail ø12x455mm
• 08052990975433: ESTREMO nail ø12x440mm