Imager Adaptor for Stryker Niagra® Retractor

GUDID 00850007069438

Imager Adaptor for Stryker Niagra® Retractor, 5-pk Carton

VISEON, INC.

General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope

• Primary Device ID: 00850007069438
• NIH Device Record Key: c08159cf-2924-4bb2-93a3-22bc1f98a1d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imager Adaptor for Stryker Niagra® Retractor
• Version Model Number: SKN-S
• Company DUNS: 096680671
• Company Name: VISEON, INC.
• Device Count: 5
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007069438 [Unit of Use]
GS1	00850007069476 [Primary]

FDA Product Code

• FSO: Microscope, Surgical, General & Plastic Surgery

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: 2024-02-13
• Device Publish Date: 2024-02-05

Devices Manufactured by VISEON, INC.

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• 00850007069353 - MaxView System - Lateral Set: 2024-02-13 MaxView System - Lateral Set Gen 2, Long
• 00850007069360 - Imager Adaptor for NuVasive® MaXcess® 4 Retractor: 2024-02-13 Imager Adaptor for NuVasive® MaXcess® 4 Retractor, 5 -pk Carton
• 00850007069377 - Imager Adaptor for Globus Mars™3VL Retractor: 2024-02-13 Imager Adaptor for Globus Mars™3VL Retractor, 5-pk Carton
• 00850007069391 - Imager Adaptor for Alphatec PTP™ Retractor: 2024-02-13 Imager Adaptor for Alphatec PTP™ Retractor, 5-pk Carton
• 00850007069445 - Image Control Box: 2024-02-13 Image Control Box (ICB-4K)
• 00850007069438 - Imager Adaptor for Stryker Niagra® Retractor: 2024-02-13Imager Adaptor for Stryker Niagra® Retractor, 5-pk Carton
• 00850007069438 - Imager Adaptor for Stryker Niagra® Retractor: 2024-02-13 Imager Adaptor for Stryker Niagra® Retractor, 5-pk Carton