ESTREMO EBA-5306

GUDID 08059386742501

CITIEFFE SRL

Orthopaedic bone-fragment manipulator, reusable

Primary Device ID	08059386742501
NIH Device Record Key	85fd9449-1746-4e46-ac11-c85d852f4090
Commercial Distribution Status	In Commercial Distribution
Brand Name	ESTREMO
Version Model Number	Fracture alignment guide wire exchange tool
Catalog Number	EBA-5306
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	false
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

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	08059386742501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181540

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories