Pediatric Nailing Platform | Tibia

Basic Information

• Brand Name: Pediatric Nailing Platform | Tibia
• Primary DI: 00840194429054
• Version / Model: 01-1510-0030
• Catalog Number: 01-1510-0030
• Company Name: ORTHOPEDIATRICS CORP.
• Labeler DUNS: 796416191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: 7cf93e5e-adf1-4a8c-96b1-9a944f449f77

Device Description

Canal Sizer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTY	TAPE, MEASURING, RULERS AND CALIPERS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45405	Orthopaedic x-ray ruler	A device used in an orthopaedic clinical setting to establish an accurate measurement of length or size related to a bone structure (i.e., length, thickness, or other aspects) when this is being viewed by the surgeon during fluoroscopy. It is a smooth-edged strip, typically made of stainless steel, that is marked in units of length (i.e., inches and/or millimetres) and includes a series of notches and holes that clearly show up on the x-ray image demonstrating the distances of the viewed bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840194429054	GS1