DEVICE: Piccolo Composite Plate System (07290109339757)

Device Identifier (DI) Information

Piccolo Composite Plate System
Targeting Guide - Narrow Left
In Commercial Distribution
PLL92100
CARBOFIX ORTHOPEDICS LTD
07290109339757
GS1

1
649185170 *Terms of Use
Targeting Guide for use with the Piccolo Composite Distal Radius Plate System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Orthopaedic implant aiming/guiding block, reusable A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102597 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
No Device Sizes
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Device Record Status

5699ea0d-9773-4b76-90e6-f4d73f94615a
July 06, 2018
3
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
No
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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