DEVICE: Piccolo Composite Nailing System (07290109338736)

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Device Identifier (DI) Information

Piccolo Composite Nailing System
Drill Bit
PN940250US
CARBOFIX ORTHOPEDICS LTD
07290109338736
GS1
1
Step Drill Bit for use with the Piccolo Composite Tibial and Femoral Nailing Systems
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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.
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FDA Product Code

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Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 4.0 Millimeter
Length: 250 Millimeter
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Device Status

In Commercial Distribution
September 18, 2016

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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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1-800-408-0120
usa@carbo-fix.com
+97299511511
info@carbo-fix.com
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