Colibri micro ENT scope ERW-0100

GUDID 07290016539103

Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.

3NT MEDICAL LTD

Rigid video otorhinolaryngoscope

• Primary Device ID: 07290016539103
• NIH Device Record Key: 0a788c81-22a8-444d-8e76-df856ae66f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colibri micro ENT scope
• Version Model Number: ERW-0100
• Catalog Number: ERW-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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016539103 [Primary]
GS1	07290016539110 [Package]; Package: 10Pack [10 Units]; In Commercial Distribution
GS1	57290016539108 [Package]; Package: 5-pack [5 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-11
• Device Publish Date: 2020-05-21

Devices Manufactured by 3NT MEDICAL LTD

• 07290016539103 - Colibri micro ENT scope: 2024-11-11Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
• 07290016539103 - Colibri micro ENT scope: 2024-11-11 Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagn
• 17290016539223 - Colibri micro-ENT Scope: 2024-01-08 Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagn
• 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: 2021-02-22 The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes.