AccessGUDID - DEVICE: Piccolo Composite Nailing System (07290109338781)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Nailing System
Version or Model: Exchange Tube
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PFT912240
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109338781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Exchange Tube for use with the Piccolo Composite Proximal Femur Nailing 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:	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58148	Orthopaedic implantation sleeve, single-use	A sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, to stabilize an instrument/implant coupling, and/or to protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a single-use device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151010	000
K153536	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8bf19b0-ffff-4771-897b-30610e462438
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 18, 2016