Open Field Fluorescence Imaging Head

GUDID 06973031299580

Guangdong Optomedic Technologies, Inc.

Surgical video camera

• Primary Device ID: 06973031299580
• NIH Device Record Key: 0d87af6d-c26e-493c-9039-da615f707b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Open Field Fluorescence Imaging Head
• Version Model Number: OPTO-CHD314KE
• Company DUNS: 544527790
• Company Name: Guangdong Optomedic Technologies, 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: 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	06973031299580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230407

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-02
• Device Publish Date: 2024-03-25

Devices Manufactured by Guangdong Optomedic Technologies, Inc.

• 06973031299337 - 3D Laparoscope: 2024-08-23
• 06973031299344 - 3D Laparoscope: 2024-08-23
• 06973031299375 - Stellar Light Source: 2024-08-23
• 06973031299382 - Stellar Exoscope: 2024-08-23
• 06973031299399 - Stellar 3D Fluorescence Camera Head: 2024-08-23
• 06973031299405 - Stellar 3D Camera Head: 2024-08-23
• 06973031299412 - Stellar Fluorescence Camera Head: 2024-08-23
• 06973031299429 - Stellar Camera Head: 2024-08-23