IlluminOss CT-0313

GUDID M986CT03130

DRILL BIT, 3.5mm DIA x 7" LG.

ILLUMINOSS MEDICAL, INC.

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: M986CT03130
• NIH Device Record Key: 15ab594a-63f1-440b-9d8c-10378b32d25c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IlluminOss
• Version Model Number: CT-0313
• Catalog Number: CT-0313
• Company DUNS: 859664661
• Company Name: ILLUMINOSS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M986CT03130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160062

FDA Product Code

• QAD: Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-21
• Device Publish Date: 2022-03-11

On-Brand Devices [IlluminOss]

• M986SY2000010: Photodynamic Curing System
• M986CT03010: Separator, mini-SF
• M986CT01970: Stabilizer Handle, Collet-type, mini-SF
• M986CT01960: Separator- Lever Lock
• M986CT01950: Flex Tube Cutter, mini-SF
• M986CT01880: Stabilizer, Chuck Handle Assy
• M986CT01860: Flex Stabilizer Tube 3.5” Long
• M986CT03170: DRILL BIT, 6.5mm DIA x 7" LG.
• M986CT03160: DRILL BIT, 5.0mm DIA x 7" LG.
• M986CT03150: DRILL BIT, 4.5mm DIA x 7" LG.
• M986CT03140: DRILL BIT, 4.0mm DIA x 7" LG.
• M986CT03130: DRILL BIT, 3.5mm DIA x 7" LG.
• M986CT03120: DRILL BIT, 3.2mm DIA x 7" LG.
• M986CT03110: GUIDEWIRE, TROCAR TIP, 2.8mm
• M986CT03100: GUIDEWIRE, TROCAR TIP, 2.5mm
• M986CT03090: GUIDEWIRE, TROCAR TIP, 2.0mm
• M986CT03080: GUIDEWIRE, TROCAR TIP, 1.8mm
• M986CT03070: GUIDEWIRE, TROCAR TIP, 1.6mm
• M986CT03180: DRILL BIT, 7.3mm DIA x 7" LG.