ISEN-Goggles

GUDID B499V062

The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of pat

ISEN Tech. & Trading Co.,Ltd.

Nystagmus inducing optokinetic drum

• Primary Device ID: B499V062
• NIH Device Record Key: 322563a2-dbd7-4eec-b362-86b550f25654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISEN-Goggles
• Version Model Number: V06
• Company DUNS: 527141254
• Company Name: ISEN Tech. & Trading Co.,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: true
• Serial Number: false
• 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: 954-591-9309
• Email: sliu@colandmedical.com
• Phone: 954-591-9309
• Email: sliu@colandmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B499V060 [Primary]
HIBCC	B499V061 [Package]; Contains: B499V060; Package: [1 Units]; In Commercial Distribution
HIBCC	B499V062 [Package]; Contains: B499V061; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152727

FDA Product Code

• GWN: Nystagmograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-01