Contours VPS Volar Plating System DH0434CE

GUDID 18054242516200

DRILL BIT, 1.6 MM, QUICK CONNECT

ORTHOFIX SRL

Fluted surgical drill bit, reusable
Primary Device ID18054242516200
NIH Device Record Keya6da2c08-b31d-4f68-a838-6379d33164cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameContours VPS Volar Plating System
Version Model Number1
Catalog NumberDH0434CE
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exempttrue
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+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242516200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18054242516200]

Moist Heat or Steam Sterilization


[18054242516200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-22
Device Publish Date2016-12-01

On-Brand Devices [Contours VPS Volar Plating System]

18054242517078PLATE, DISTAL RADIUS VOLAR, RIGHT, WIDE, LONG
18054242517061PLATE, DISTAL RADIUS VOLAR, RIGHT, WIDE, SHORT
18054242517054PLATE, DISTAL RADIUS VOLAR, RIGHT, STANDARD, XLONG
18054242517047PLATE, DISTAL RADIUS VOLAR, RIGHT, STANDARD, LONG
18054242517030PLATE, DISTAL RADIUS VOLAR, RIGHT, STANDARD, SHORT
18054242517023PLATE, DISTAL RADIUS VOLAR, RIGHT, NARROW, LONG
18054242517016PLATE, DISTAL RADIUS VOLAR, RIGHT, NARROW, SHORT
18054242517009PLATE, DISTAL RADIUS VOLAR, MOD SCREW ANGLES, RIGHT, C1, LONG LENGTH, TITANIUM
18054242516996PLATE, DISTAL RADIUS VOLAR, MOD SCREW ANGLES, RIGHT, C1, STD LENGTH, TITANIUM
18054242516989PLATE, VOLAR DISTAL RADIUS, RIGHT, C2, LONG LENGTH, TITANIUM
18054242516972PLATE, VOLAR DISTAL RADIUS, RIGHT, C1, LONG LENGTH, TITANIUM
18054242516965PLATE, VOLAR DISTAL RADIUS, RIGHT, C2, STD LENGTH, TITANIUM
18054242516958PLATE, VOLAR DISTAL RADIUS, RIGHT, C1, STD LENGTH, TITANIUM
18054242516941PLATE, DISTAL RADIUS VOLAR, LEFT, WIDE, LONG
18054242516934PLATE, DISTAL RADIUS VOLAR, LEFT, WIDE, SHORT
18054242516927PLATE, DISTAL RADIUS VOLAR, LEFT, STANDARD, XLONG
18054242516910PLATE, DISTAL RADIUS VOLAR, LEFT, STANDARD, LONG
18054242516903PLATE, DISTAL RADIUS VOLAR, LEFT, NARROW, LONG
18054242516897PLATE, DISTAL RADIUS VOLAR, LEFT, NARROW, LONG
18054242516880TEMPLATE FOR VPS3 PLATE
18054242516873PLATE, DISTAL VOLAR RADIUS, MOD. SCREW ANGLES, LEFT, C1, LONG LENGTH, TITANIUM
18054242516866PLATE, DISTAL VOLAR RADIUS, MOD. SCREW ANGLES, LEFT, C1, STD LENGTH, TITANIUM
18054242516859PLATE, VOLAR DISTAL RADIUS, LEFT, C2, LONG LENGTH, TITANIUM
18054242516842PLATE, VOLAR DISTAL RADIUS, LEFT, C1, LONG LENGTH, TITANIUM
18054242516835PLATE, VOLAR DISTAL RADIUS, LEFT, C2, STD LENGTH, TITANIUM
18054242516828PLATE, VOLAR DISTAL RADIUS, LEFT, C1, STD LENGTH, TITANIUM
18054242516811SCREW, 3.5 MM X 1.25 X 18 MM W/2.5 MM HEX, BONE
18054242516804SCREW, 3.5 MM X 1.25 X 16 MM W/2.5 MM HEX, BONE
18054242516798SCREW, 3.5 MM X 1.25 X 14 MM W/2.5 MM HEX, BONE
18054242516781SCREW, 3.5 MM X 1.25 X 12 MM W/2.5 MM HEX, BONE
18054242516774SCREW, 3.5 MM X 1.25 X 10 MM W/2.5 MM HEX, BONE
18054242516767SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 20 MM ASTM TYPE HA, TITANIUM
18054242516750SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 18 MM ASTM TYPE HA, TITANIUM
18054242516743SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 16 MM ASTM TYPE HA, TITANIUM
18054242516736SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 14 MM ASTM TYPE HA, TITANIUM
18054242516729SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 12 MM ASTM TYPE HA, TITANIUM
18054242516712SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 10 MM ASTM TYPE HA, TITANIUM
18054242516705SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 28X21, TITANIUM
18054242516699SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 26X19.5, TITANIUM
18054242516682SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 24X18, TITANIUM
18054242516675SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 22X16.5, TITANIUM
18054242516668SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 20X15, TITANIUM
18054242516651SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 18X13.5, TITANIUM
18054242516644SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 16X12, TITANIUM
18054242516637SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 14X10.5, TITANIUM
18054242516620SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 12X8.5, TITANIUM
18054242516613SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 24X18, TITANIUM
18054242516606SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 22X16.5, TITANIUM
18054242516590SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 20X15, TITANIUM
18054242516583SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 18X13.5, TITANIUM

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