3NT Video Console CCU-0100

GUDID 07290016539097

The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes.

3NT MEDICAL LTD

Endoscopic video image processing unit

• Primary Device ID: 07290016539097
• NIH Device Record Key: a3c61d29-6883-43f4-af81-16e600a5ec54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3NT Video Console
• Version Model Number: CCU-0100
• Catalog Number: CCU-0100
• Company DUNS: 600235289
• Company Name: 3NT MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016539097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192305

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-22
• Device Publish Date: 2020-05-21

Devices Manufactured by 3NT MEDICAL LTD

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• 07290016539073 - Peregrine drivable ENT scope: 2023-12-19 The Peregrine Drivable ENT Scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities dur
• 07290016539202 - 3NT Video Console 2: 2021-03-01 The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes.
• 07290016539097 - 3NT Video Console: 2021-02-22The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes.
• 07290016539097 - 3NT Video Console: 2021-02-22 The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes.