Photodynamic Bone Stabilization Procedure Pack

FDA UDI

Class II (US FDA UDI)

by Illuminoss Medical Inc.

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-1100220 FDA UDI
Description: Photodynamic Bone Stabilization Procedure Pack FDA UDI

Identifiers

Catalog Number: USSL-11100220 FDA UDI
Primary DI / UDI-DI: M986USSL11002200 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Photodynamic Bone Stabilization Procedure Pack by Illuminoss Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 0deaae99-75ef-49b3-89e6-d8bbf9185ac4 35 fields · synced May 30, 2026