AccessGUDID - DEVICE: Photodynamic Bone Stabilization Procedure Pack (M986USSL22132600)

GUDID

Device Identifier (DI) Information

Brand Name: Photodynamic Bone Stabilization Procedure Pack
Version or Model: USSL-2213260
Commercial Distribution Status: In Commercial Distribution
Catalog Number: USSL-2213260
Company Name: ILLUMINOSS MEDICAL, INC.

Primary DI Number: M986USSL22132600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 859664661 *Terms of Use

Device Description: Photodynamic Bone Stabilization Procedure Pack

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QAD	Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160062	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 067aedf1-1015-4c2e-8307-372c200a6d26
Public Version Date: July 14, 2025
Public Version Number: 3
DI Record Publish Date: August 28, 2020