FDA UDI In Commercial Distribution 🇺🇸 United States

Photodynamic Bone Stabilization System

DI: M986SY2100010 · Model: SY210001 · ILLUMINOSS MEDICAL, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Photodynamic Bone Stabilization System
Primary DI
M986SY2100010
Version / Model
SY210001
Catalog Number
SY-2100-01
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
2025-01-30
Public Version Status
Update
Public Device Record Key
4a9ee3e2-3dac-4f63-9bad-e5e3e8fc08ea

Device Description

Photodynamic Bone Stabilization LED Light Box

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

GMDN Terms

Code Name
32037 General-purpose light source

Identifiers

Type ID
Primary M986SY2100010