Orthofix Pro-View Minimal Access Portal System 006570

GUDID 00812432022402

LUMITEX, INC.

Open surgical site internal light source

• Primary Device ID: 00812432022402
• NIH Device Record Key: 4469288d-2b19-4848-9754-0fff339c7d85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthofix Pro-View Minimal Access Portal System
• Version Model Number: 70-2304
• Catalog Number: 006570
• 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	00812432022402 [Primary]
GS1	10812432022409 [Package]; Package: Carton [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: 2021-10-04
• Device Publish Date: 2021-09-24

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