lmaging Processor System (lncluding Light Source)

GUDID 06973786290139

Shanghai SeeGen Photoelectric Technology Co., Ltd

Endoscopic video image processing/light source system

• Primary Device ID: 06973786290139
• NIH Device Record Key: e3e21415-e5b6-4d3b-a860-f5554c84510a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: lmaging Processor System (lncluding Light Source)
• Version Model Number: PL-2100
• Company DUNS: 416472832
• Company Name: Shanghai SeeGen Photoelectric Technology 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06973786290139 [Primary]
GS1	16973786290181 [Package]; Package: Outer package [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241532

FDA Product Code

• FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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: 2024-10-28
• Device Publish Date: 2023-07-26

On-Brand Devices [lmaging Processor System (lncluding Light Source)]

• 06973786290115: PL-2100
• 06973786290078: PL-1000
• 06973786290139: PL-2100