L&K Biomed BluEX Surgical Illuminator

GUDID 00812432023072

LUMITEX, INC.

Open surgical site internal light

• Primary Device ID: 00812432023072
• NIH Device Record Key: a5e76b1f-248d-4777-a03d-e034fa51c225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L&K Biomed BluEX Surgical Illuminator
• Version Model Number: BR06-0001S
• Company DUNS: 108631797
• Company Name: LUMITEX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812432023072 [Primary]

FDA Product Code

• FDG: Retractor, Fiberoptic

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: 2025-12-19
• Device Publish Date: 2025-12-11

Devices Manufactured by LUMITEX, INC.

• 00812432022945 - Spineart Storz Cable Adaptor: 2026-01-30
• 00812432023096 - Lumitex Surgical Illuminator: 2026-01-26
• 00812432023164 - Medtronic 4mm Universal Reusable Light Cable: 2026-01-15
• 00812432023171 - Medtronic 4mm ACMI Cable Adapter: 2026-01-15
• 00812432023188 - Medtronic 4mm WOLF Cable Adapter: 2026-01-15
• 00812432023195 - Medtronic 4mm OLYMPUS Cable Adapter: 2026-01-15
• 00812432023201 - Medtronic 4mm STORZ Cable Adapter: 2026-01-15
• 00812432023072 - L&K Biomed BluEX Surgical Illuminator: 2025-12-19
• 00812432023072 - L&K Biomed BluEX Surgical Illuminator: 2025-12-19