Identity
- Trade Name
- Photodynamic Bone Stabilization Procedure Pack FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Photodynamic Bone Stabilization Procedure Pack FDA UDI
- Model / Reference
- USSL-2213240 FDA UDI
- Description
- Photodynamic Bone Stabilization Procedure Pack FDA UDI
Identifiers
- Catalog Number
- USSL2213240 FDA UDI
- Primary DI / UDI-DI
- USSL2213240 FDA UDI
- 510(k) Number
- DEN160062 FDA UDI
- FDA Product Code
- QAD FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3023 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Photodynamic Bone Stabilization Procedure Pack by Illuminoss Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
DEN160062 also covers:
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Illuminoss Medical Inc.
Sources (1)
- FDA UDI 2328736f-0bde-4f0c-b77d-4c39defe5b22 36 fields · synced May 30, 2026