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 | Definition | Implantable | Status |
|---|---|---|---|---|
| 32037 | General-purpose light source | A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M986SY2100010 | HIBCC |