K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA

Basic Information

• Brand Name: K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA
• Primary DI: 07290115934816
• Version / Model: 87302
• Company Name: PREMIA SPINE LTD
• Labeler DUNS: 649220779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-05
• Public Version: 2
• Public Version Date: 2025-09-17
• Public Version Status: Update
• Public Device Record Key: 6c7d4596-d3bc-4cec-baa7-8b9c32274956

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
QWK	Prosthesis, Posterior Spinal Elements	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63819	Spinal guidewire	A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290115934816	GS1