HINGE PEDIATRIC PLATING SYSTEM

Basic Information

• Brand Name: HINGE PEDIATRIC PLATING SYSTEM
• Primary DI: 07540194007759
• Version / Model: HPW150-PKG2
• Catalog Number: HPW150-PKG2
• Company Name: Pega Medical Inc
• Labeler DUNS: 257315713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-11-16
• Public Version: 1
• Public Version Date: 2023-11-24
• Public Version Status: New
• Public Device Record Key: 368b6ede-e8c2-4207-871b-332fec053d85

Device Description

HINGE PLATE GUIDE WIRE Ø1.1mm- PACKAGE OF 2

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
LXH	Orthopedic manual surgical instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46165	Orthopaedic guidewire, reusable	A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07540194010735	GS1
Primary	07540194007759	GS1

Customer Contacts

• Phone: [phone] ext. 242
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.1	Millimeter