DEVICE: Piccolo Composite Plate System (07290110200741)

Device Identifier (DI) Information

Piccolo Composite Plate System
Periosteal Elevator
In Commercial Distribution
PL921800
CARBOFIX ORTHOPEDICS LTD
07290110200741
GS1

1
649185170 *Terms of Use
Periosteal Elevator for use with the Piccolo Composite Distal Radius Plate Systems
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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
Periosteal elevator A hand-held, manually-operated surgical instrument used to lift/separate (elevate) or tunnel under the periosteum (membrane of fibrous connective tissue tightly surrounding bone or teeth) typically during dental, ophthalmic, or orthopaedic surgery. In design it is similar to a raspatory, but is typically a much finer instrument, often double-ended with a central handle. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument made of high-grade stainless steel and is available in various sizes and blade shapes. 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 [?]
K102597 000
K160002 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

6ec7b047-9d0d-48b8-9e2b-776da44f9667
July 06, 2018
3
October 10, 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

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