DEVICE: Piccolo Composite Plate System (07290109333465)

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Device Identifier (DI) Information

Piccolo Composite Plate System
Proximal Humerus Plate
PPHNN3508
CARBOFIX ORTHOPEDICS LTD
07290109333465
GS1
1
A plate indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
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Device Characteristics

MR Conditional
No
No
Yes
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 fixation plate, non-bioabsorbable, sterile A sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).
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FDA Product Code

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Product Code Product Code Name
HRS Plate, Fixation, Bone
HWC Screw, Fixation, Bone
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
Length: 192 Millimeter
Device Size Text, specify: Number of Shaft Holes: 8
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Device Status

In Commercial Distribution
October 15, 2015

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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
Yes
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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