DEVICE: Piccolo Composite Plate System (07290109337807)

Device Identifier (DI) Information

Piccolo Composite Plate System
Opening Pin
In Commercial Distribution
PFT912220
CARBOFIX ORTHOPEDICS LTD
07290109337807
GS1

1
649185170 *Terms of Use
Handle for use with the Piccolo Composite Distal Femur 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
Surgical instrument handle, non-torque-limiting A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K143496 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

4360099e-88d8-4d0e-8e4e-97a821dda47e
August 09, 2018
4
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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