Photodynamic Bone Stabilization System

Basic Information

• Brand Name: Photodynamic Bone Stabilization System
• Primary DI: M986US22001000
• Version / Model: US2200100
• Catalog Number: US-2200100
• Company Name: ILLUMINOSS MEDICAL, INC.
• Labeler DUNS: 859664661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-21
• Public Version: 2
• Public Version Date: 2025-07-14
• Public Version Status: Update
• Public Device Record Key: 0ee1c216-23f8-4677-b9d0-792a5738d31d

Device Description

22mmx100mm Photodynamic Bone Stabilization LED Light System

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M986US22001000	HIBCC