ESTREMO EBA-5306

GUDID 08059386742501

CITIEFFE SRL

Orthopaedic bone-fragment manipulator, reusable
Primary Device ID08059386742501
NIH Device Record Key85fd9449-1746-4e46-ac11-c85d852f4090
Commercial Distribution StatusIn Commercial Distribution
Brand NameESTREMO
Version Model NumberFracture alignment guide wire exchange tool
Catalog NumberEBA-5306
Company DUNS431406875
Company NameCITIEFFE SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com
Phone+39051721850
Emailinfo@citieffe.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS108059386742501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


[08059386742501]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-24
Device Publish Date2024-07-16

On-Brand Devices [ESTREMO]

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

Trademark Results [ESTREMO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESTREMO
ESTREMO
87940266 5669211 Live/Registered
Estremo Fitness, Inc.
2018-05-29
ESTREMO
ESTREMO
86874693 not registered Live/Pending
Sentury Tire USA Inc.
2016-01-13

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