AccessGUDID - DEVICE: Piccolo Composite Plate System (07290109339450)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Plate System
Version or Model: Template - 6H Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PLLF0460
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109339450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Template for use with the Piccolo Composite Distal Fibula Plate System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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
Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical implant template, reusable

A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120409	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 52ee6042-f1a3-48d3-ae76-4771c24d9c0d
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 18, 2016