Piccolo Composite Plate System PRN92104

GUDID 07290109339917

Template for use with the Piccolo Composite Distal Radius Plate System

CARBOFIX ORTHOPEDICS LTD

Surgical implant template, reusable
Primary Device ID07290109339917
NIH Device Record Key5f1f42f9-dbbf-4eb6-a0b5-b6c6b43e0896
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiccolo Composite Plate System
Version Model NumberTemplate - Narrow Right
Catalog NumberPRN92104
Company DUNS649185170
Company NameCARBOFIX ORTHOPEDICS LTD
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97299511511
Emailinfo@carbo-fix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109339917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109339917]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-18

On-Brand Devices [Piccolo Composite Plate System]

07290110205119Template for use with the Piccolo Composite Lapidus Plate System
07290110205102Template for use with the Piccolo Composite Lapidus Plate System
07290110205096Template for use with the Piccolo Composite Lapidus Plate System
07290110205072A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
07290110205065A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
07290110205058A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
07290110204372Template for use with the Piccolo Composite Broad Diaphyseal Plate System
07290110202262Sterilization case for use with the Piccolo Composite MTP Plate System.
07290110201708A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201692A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201630A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201623A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201487Holding device for use with the Piccolo Composite MTP Plate System
07290110201470Sleeve for use with the Piccolo Composite Foot and Ankle Plate Systems
07290110201463Non-locking screw for use with distal fibula, MTP and Lapidus plates
07290110201456Non-locking screw for use with distal fibula, MTP and Lapidus plates
07290110201449Locking screw for use with distal fibula, MTP and Lapidus plates
07290110201432Locking screw for use with distal fibula, MTP and Lapidus plates
07290110201425A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201418Targeting Guide for use with the Piccolo Composite Proximal Humerus Plate System
07290110201296Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201289Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201272Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201265Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201258Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201241Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201234Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201227Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201210Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201203Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201074Depth Gauge for use with the Piccolo Composite MTP Plate System.
07290110201067Template for use with the Piccolo Composite MTP Plate System
07290110201050Template for use with the Piccolo Composite MTP Plate System
07290110201043Drill Bit for use with the Piccolo Composite MTP Plate System
07290110201036Screwdriver for use with the Piccolo Composite MTP Plate System.
07290110201029K-Wire for use with the Piccolo Composite MTP Plate System
07290110201012K-Wire for use with the Piccolo Composite MTP Plate System
07290110201005K-Wire for use with the Piccolo Composite MTP Plate System
07290110200992A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110200916Torque Limiter for use with the Piccolo Composite Distal Radius Plate System
07290110200749Periosteal Elevator for use with the Piccolo Composite Distal Radius Plate Systems
07290110200732Retractor for use with the Piccolo Composite Distal Radius Plate Systems
07290110200541Sterilization case for use with the Piccolo Composite Distal Radius Plate Systems
07290110200510Retractor for use with the Piccolo Composite Distal Radius Plate Systems
07290110200503Sleeve for use with the Piccolo Composite Distal Radius Plate Systems
07290110200480Sterilization case for use with the Piccolo Composite Foot and Ankle Plate Systems
07290109339931Template for use with the Piccolo Composite Distal Radius Plate System
07290109339924Template for use with the Piccolo Composite Distal Radius Plate System
07290109339917Template for use with the Piccolo Composite Distal Radius Plate System
07290109339900Template for use with the Piccolo Composite Distal Radius Plate System

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