CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE TP3108

GUDID 18054242510574

PLATE HOLDER

ORTHOFIX SRL

Orthopaedic implant inserter/extractor, reusable
Primary Device ID18054242510574
NIH Device Record Keyb0bec670-2c0c-48d5-8b8e-e0344ada99e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE
Version Model Number1
Catalog NumberTP3108
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 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+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Dimensions

Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter
Width149 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242510574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


[18054242510574]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2018-05-08

On-Brand Devices [CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE]

18054242510611RULER
18054242510574PLATE HOLDER
18054242510550DRILL GUIDE (D. 3.2MM)
18032937169269MEASURER 2

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