Novus N-Sight Disposable Surgical Light NS-DRL-5

GUDID 10812432021532

LUMITEX, INC.

Surgical instrument fibreoptic light

• Primary Device ID: 10812432021532
• NIH Device Record Key: 9723529f-ffe8-4739-a097-40b2fe3efb4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novus N-Sight Disposable Surgical Light
• Version Model Number: 010816
• Catalog Number: NS-DRL-5
• 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	00812432021535 [Primary]
GS1	10812432021532 [Package]; Contains: 00812432021535; Package: [5 Units]; In Commercial Distribution

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

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