AccessGUDID - DEVICE: Piccolo Composite Nailing System (07290109332338)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Nailing System
Version or Model: Tibial Nail
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PTN11260
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109332338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Tibial nail indicated for simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the tibia.

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
Tibia nail, sterile	A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Tibia nail, sterile

A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102369	000
K111056	000
K132774	000

Device Exempt from Premarket Submission: No CLOSE

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: 260 Millimeter
Outer Diameter: 11 Millimeter
Device Size Text, specify: Proximal Diameter: 11.5 Millimeter

Device Record Status

Public Device Record Key: 7f53032b-7552-482d-963f-390a61bfcb84
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 15, 2015