Image Processing Unit

GUDID 06973031299832

Guangdong Optomedic Technologies, Inc.

Stationary general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 06973031299832
• NIH Device Record Key: c6c027c8-6699-40b3-aaa9-930fe8db119e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image Processing Unit
• Version Model Number: OPTO-CAM2100
• 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	06973031299832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221861

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2024-04-03
• Device Publish Date: 2024-03-26

On-Brand Devices [Image Processing Unit]

• 06973031299917: OPTO-CAM104K
• 06973031299832: OPTO-CAM2100