DEVICE: Piccolo Composite Plate System (07290109339450)
Device Identifier (DI) Information
Piccolo Composite Plate System
Template - 6H Left
In Commercial Distribution
PLLF0460
CARBOFIX ORTHOPEDICS LTD
Template - 6H Left
In Commercial Distribution
PLLF0460
CARBOFIX ORTHOPEDICS LTD
Template for use with the Piccolo Composite Distal Fibula Plate System
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Surgical implant template, reusable | A device designed to determine the appropriate size and placement of an implant for a patient prior to or during surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | Plate, Fixation, Bone |
KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
52ee6042-f1a3-48d3-ae76-4771c24d9c0d
March 29, 2018
2
September 18, 2016
March 29, 2018
2
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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+97299511511
info@carbo-fix.com 1-800-408-0120
usa@carbo-fix.com
info@carbo-fix.com 1-800-408-0120
usa@carbo-fix.com