Contours Proximal Humeral Plate (PHP) 99-1-TP3107

GUDID 18054242510512

CANNULATED DRILL BIT (D. 4.8MM) 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 ID18054242510512
NIH Device Record Keyea01b794-a114-4a3c-b133-487bb707bb83
Commercial Distribution StatusIn Commercial Distribution
Brand NameContours Proximal Humeral Plate (PHP)
Version Model Number1
Catalog Number99-1-TP3107
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 Usetrue
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 Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242510512 [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 [Contours Proximal Humeral Plate (PHP)]

18054242510512CANNULATED DRILL BIT (D. 4.8MM) QUICK CONNECT STERILE
18054242510499FINE THREADED SCREWS (D. 2.2MM) L. 120/55MM (PACK OF 2) STERILE
18054242510482FINE THREADED SCREWS (D. 2.2MM) L. 120/50MM (PACK OF 2) STERILE
18054242510475FINE THREADED SCREWS (D. 2.2MM) L. 120/45MM (PACK OF 2) STERILE
18054242510468FINE THREADED SCREWS (D. 2.2MM) L. 120/40MM (PACK OF 2) STERILE
18054242510451FINE THREADED SCREWS (D. 2.2MM) L. 120/35MM (PACK OF 2) STERILE
18054242510444FINE THREADED SCREWS (D. 2.2MM) L. 120/30MM (PACK OF 2) STERILE
18054242510437FINE THREADED SCREWS (D. 2.2MM) L. 120/25MM (PACK OF 2) STERILE
18054242510420FINE THREADED SCREWS (D. 2.2MM) L. 120/20MM (PACK OF 2) STERILE
18054242510413REVISION SCREW (D. 6.5MM) L. 34MM STERILE
18054242510406REVISION SCREW (D. 6.5MM) L. 32MM STERILE
18054242510390REVISION SCREW (D. 6.5MM) L. 30MM STERILE
18054242510383REVISION SCREW (D. 6.5MM) L. 28MM STERILE
18054242510376REVISION SCREW (D. 6.5MM) L. 26MM STERILE
18054242510369DIAPHYSEAL SCREW (D. 4.5 MM) L. 36MM STERILE
18054242510352DIAPHYSEAL SCREW (D. 4.5 MM) L. 34MM STERILE
18054242510345DIAPHYSEAL SCREW (D. 4.5 MM) L. 32MM STERILE
18054242510338DIAPHYSEAL SCREW (D. 4.5 MM) L. 30MM STERILE
18054242510321DIAPHYSEAL SCREW (D. 4.5 MM) L. 28MM STERILE
18054242510314DIAPHYSEAL SCREW (D. 4.5 MM) L. 26MM STERILE
18054242510307DIAPHYSEAL SCREW (D. 4.5 MM) L. 24MM STERILE
18054242510291DIAPHYSEAL SCREW (D. 4.5 MM) L. 22MM STERILE
18054242510284MAIN LOCKING SCREW (D. 6.0 MM) L. 60MM STERILE
18054242510277MAIN LOCKING SCREW (D. 6.0 MM) L. 55MM STERILE
18054242510260MAIN LOCKING SCREW (D. 6.0 MM) L. 50MM STERILE
18054242510253MAIN LOCKING SCREW (D. 6.0 MM) L. 45MM STERILE
18054242510246MAIN LOCKING SCREW (D. 6.0 MM) L. 40MM STERILE
18054242510239CONTOURS PHP PROX. HUMERAL PLATE LEFT STERILE
18054242510222CONTOURS PHP PROX. HUMERAL PLATE RIGHT STERILE
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