AccessGUDID - DEVICE: Piccolo Composite Plate System (07290109334783)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Plate System
Version or Model: One-Third Tubular Plate
Catalog Number: POTTN2009
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109334783
Issuing Agency: GS1
Device Count: 1

Device Description: A plate indicated for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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).

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).

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

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 98 Millimeter
Device Size Text, specify: Number of Shaft Holes: 9

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: October 18, 2015
Commercial Distribution End Date:

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

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Phone: +97299511511
Email: info@carbo-fix.com

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DEVICE: Piccolo Composite Plate System (07290109334783)