June Medical Galaxy II LUX Connect Surgical Illuminator JUNELuxC1

GUDID 00812432022471

LUMITEX, INC.

Open surgical site internal light source

• Primary Device ID: 00812432022471
• NIH Device Record Key: 40602910-94cc-48e1-8708-2f3917ca7edd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: June Medical Galaxy II LUX Connect Surgical Illuminator
• Version Model Number: 012569
• Catalog Number: JUNELuxC1
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812432022471 [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: 2021-08-02
• Device Publish Date: 2021-07-23

Devices Manufactured by LUMITEX, INC.

• 00812432023041 - Precision Spine TLIF Bifurcated Surgical Illuminator: 2024-11-04
• 00812432023058 - Lattus Spine Surgical Illuminator: 2024-07-01
• 00812432023010 - Thompson Surgical Instruments Lite Path Integrated Double 13mm: 2023-11-09
• 00812432022396 - Spineart Wolf Cable Adaptor: 2023-08-21
• 00812432022921 - Spineart Olympus Cable Adaptor: 2023-08-21
• 00810025485344 - MiRus Bifurcated Illuminator: 2023-08-21
• 00812432021559 - Spineart Storz Cable Adaptor: 2023-08-21
• 00812432021689 - Lumitex 4mm Universal Fiber Optic Cable: 2023-08-21