Endoscopic Fluorescence Camera Head

GUDID 06973031299535

Guangdong Optomedic Technologies, Inc.

Endoscope video camera

• Primary Device ID: 06973031299535
• NIH Device Record Key: f0f54c26-c02a-4a04-898b-1aa777be45ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoscopic Fluorescence Camera Head
• Version Model Number: 71-068-20 NIR-CA
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973031299535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221861

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

[06973031299535]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [Endoscopic Fluorescence Camera Head]

• 06973031299542: 71-068-10 NIR-CA
• 06973031299535: 71-068-20 NIR-CA