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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38152	Tibia intramedullary nail	A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It 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.	Active	true

FDA Product Code

[?]

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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: February 06, 2025
Public Version Number: 5
DI Record Publish Date: October 15, 2015