Threaded Hand Nail

Basic Information

• Brand Name: Threaded Hand Nail
• Primary DI: 00841506115283
• Version / Model: K-Wire, 0.9mm x 152mm, Single Trocar
• Catalog Number: KWIR-ST-09152
• Company Name: SKELETAL DYNAMICS L.L.C.
• Labeler DUNS: 869056148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-22
• Public Version: 1
• Public Version Date: 2024-01-01
• Public Version Status: New
• Public Device Record Key: fd6bc19e-019d-4120-84bf-1ab4145813ac

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: No
• PM Exempt: No
• 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
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62729	Orthopaedic guidewire, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841506115283	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]