GUDID 04582275270020

KONAN MEDICAL USA, INC.

Vision electrophysiology analysis system

• Primary Device ID: 04582275270020
• NIH Device Record Key: 0fbbed02-abad-440c-b253-2de5d96b6829
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EV-001
• Company DUNS: 788439219
• Company Name: KONAN MEDICAL USA, 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582275270020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081591

FDA Product Code

• GWE: Stimulator, photic, evoked response

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: 2016-09-23

Devices Manufactured by KONAN MEDICAL USA, INC.

• 04582275270075 - NA: 2024-08-12
• 04582275270068 - NA: 2023-06-23
• 04582275270051 - N/A: 2019-09-17
• 04582275270020 - NA: 2018-07-06
• 04582275270020 - NA: 2018-07-06
• 04582275270037 - NA: 2018-03-29
• 04582275270044 - NA: 2018-03-29