Spineart Surgical Illuminator MIS-IN 44 70-S

GUDID 00812432021436

LUMITEX, INC.

Surgical instrument fibreoptic light

• Primary Device ID: 00812432021436
• NIH Device Record Key: 9852292d-3d2f-4d9c-91b5-f688f12d30ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spineart Surgical Illuminator
• Version Model Number: 010996
• Catalog Number: MIS-IN 44 70-S
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812432021436 [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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Spineart Surgical Illuminator]

• 00812432021436: 010996
• 00812432021429: 008612