DEVICE: Piccolo Composite Plate System (07290109338644)
Device Identifier (DI) Information
Piccolo Composite Plate System
Drill Bit
In Commercial Distribution
PL934155
CARBOFIX ORTHOPEDICS LTD
Drill Bit
In Commercial Distribution
PL934155
CARBOFIX ORTHOPEDICS LTD
Drill Bit for use with the Piccolo Composite Proximal Humerus Plate System
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Fluted surgical drill bit, 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. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
HRS | Plate, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K102597 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 125 Millimeter |
Outer Diameter: 3.4 Millimeter |
Device Record Status
d1eb537b-3926-4deb-a3a2-af9ed1d81cc6
November 22, 2018
4
September 18, 2016
November 22, 2018
4
September 18, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-408-0120
usa@carbo-fix.com +97299511511
info@carbo-fix.com
usa@carbo-fix.com +97299511511
info@carbo-fix.com