NDŌʜᴅ High Definition Imaging System (NDŌʜᴅ)

GUDID 00866861000203

The NDŌʜᴅ system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic surgical procedures including, but not limited to, orthoscopic, gynecological, laparoscopic, urologic, sinuscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDŌʜᴅ system is not intended to be used in an environment that requires sterilization.

ALTARAVISION, INC.

Endoscopic video image processing unit

• Primary Device ID: 00866861000203
• NIH Device Record Key: 9c6a7860-852e-4659-9fc3-ae059d9f6f86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NDŌʜᴅ High Definition Imaging System (NDŌʜᴅ)
• Version Model Number: 2.0
• Company DUNS: 064561659
• Company Name: ALTARAVISION, INC.
• 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: false
• 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

Customer Support Contacts

• Phone: 8773901887
• Email: info@ndohd.com
• Phone: 8773901887
• Email: info@ndohd.com
• Phone: 8773901887
• Email: info@ndohd.com
• Phone: 8773901887
• Email: info@ndohd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866861000203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131873

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-23