AccessGUDID - DEVICE: Piccolo Composite Plate System (07290109338644)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Plate System
Version or Model: Drill Bit
Catalog Number: PL934155
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109338644
Issuing Agency: GS1
Device Count: 1

Device Description: Drill Bit for use with the Piccolo Composite Proximal Humerus Plate System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Fluted surgical drill, single-use, sterile	A sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. It is typically made of high-grade stainless steel and is available in various sizes. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Fluted surgical drill, single-use, sterile

A sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. It is typically made of high-grade stainless steel and is available in various sizes. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
HRS	Plate, Fixation, Bone

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 125 Millimeter
Outer Diameter: 3.4 Millimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 18, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Phone: +97299511511
Email: info@carbo-fix.com

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DEVICE: Piccolo Composite Plate System (07290109338644)