DEVICE: Piccolo Composite Plate System (07290109337739)

Device Identifier (DI) Information

Piccolo Composite Plate System
Forceps - Bone Holding
In Commercial Distribution
DL921890
CARBOFIX ORTHOPEDICS LTD
07290109337739
GS1

1
649185170 *Terms of Use
Forceps 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
Bone holding forceps A surgical instrument used for grasping and holding a bone during a surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. 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 [?]
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

e5db9bce-626d-4266-bb19-8fef9608d1c3
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)

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

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Yes
No
No
No
No CLOSE

Customer Contact

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