DOLPHIX DF900002

GUDID 08052990972555

CITIEFFE SRL

External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 08052990972555
• NIH Device Record Key: 29372a2a-c293-40f3-9f4e-9149c2dec4d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOLPHIX
• Version Model Number: Dolphix Velcro Security Wrao (10 pcs)
• Catalog Number: DF900002
• Company DUNS: 431406875
• Company Name: CITIEFFE SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• 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
• 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
• 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
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052990972555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163323

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-24
• Device Publish Date: 2021-11-16

On-Brand Devices [DOLPHIX]

• 08051739531800: Dolphix fixator L-Rod field Kit diaphyseal
• 08052990974566: Bone screw ø6mm L200-45mm
• 08052990974559: Bone screw ø5mm L180-40mm
• 08052990974542: Bone screw ø4mm L120-30mm
• 08052990972678: Clamp with bone screw ø6mm L200-45mm
• 08052990972661: Clamp with bone screw ø5mm L180-40mm
• 08052990972654: Clamp with bone screw ø4mm L120-30mm
• 08051739531251: Bone screw ø6mm L200-45mm
• 08051739531244: Bone screw ø5mm L180-40mm
• 08051739531237: Bone screw ø4mm L120-30mm
• 08052990974535: Transfixing bone screw ø7mm L260mm
• 08032909627639: Bone screw extension
• 08052990971916: Starter kit - Titanium
• 08052990971909: Starter kit - St. Steel
• 08052990971886: Metatarsal kit - Titanium
• 08052990971879: Delta kit - Titanium
• 08052990972548: Drill bit
• 08032909625307: Drill bit
• 08052990972562: Drill brace
• 08032909625314: Drill brace
• 08052990970056: Dolphix Distractor-compactor, L
• 08056711920320: Dolphix cable ties (4 pcs)
• 08052990972555: Dolphix Velcro Security Wrao (10 pcs)