LSP Titanium Humeral Plate 99-1-TP1104

GUDID 18054242510529

DRILL BIT (D. 3.2MM) QUICK CONNECT STERILE

ORTHOFIX SRL

Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use
Primary Device ID18054242510529
NIH Device Record Keyab428e69-faef-4547-aa4a-8d310297583f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLSP Titanium Humeral Plate
Version Model Number1
Catalog Number99-1-TP1104
Company DUNS438793622
Company NameORTHOFIX 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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it

Device Dimensions

Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter
Outer Diameter3.2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242510529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2015-09-01

On-Brand Devices [LSP Titanium Humeral Plate]

18054242510529DRILL BIT (D. 3.2MM) QUICK CONNECT STERILE
18054242510505K-WIRES (D. 2MM) L. 200MM (PACK OF 4) STERILE
18033509852312LOCKING SCREW 2,4X55 MM STERILE
18033509852305LOCKING SCREW 2,4X50 MM STERILE
18033509852299LOCKING SCREW 2,4X45 MM STERILE
18033509852282LOCKING SCREW 2,4X40 MM STERILE
18033509852275LOCKING SCREW 2,4X35 MM STERILE
18033509852268LOCKING SCREW 2,4X30 MM STERILE
18033509852251LOCKING SCREW 2,4X25 MM STERILE
18033509852244LOCKING SCREW 2,4X20 MM STERILE
18033509851940LSP LEFT HUMERUS STERILE TITANIUM PLATE
18033509851933LSP RIGHT HUMERUS STERILE TITANIUM PLATE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.