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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-1100180 FDA UDI
Description
Photodynamic Bone Stabilization Procedure Pack FDA UDI

Identifiers

Primary DI / UDI-DI
USSL1100180 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

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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Illuminoss Medical Inc.

Sources (1)

  • FDA UDI 2b9ac2b7-cdd8-4f54-833a-be6571928157 35 fields · synced Jun 1, 2026