Flexible Video-Choledochoscope

GUDID 06973786290641

Shanghai SeeGen Photoelectric Technology Co., Ltd

Flexible video choledochoscope, single-use

• Primary Device ID: 06973786290641
• NIH Device Record Key: ea6fab21-a16f-4409-bde0-6c4c70df7306
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Video-Choledochoscope
• Version Model Number: CHV-US100J-U
• Company DUNS: 416472832
• Company Name: Shanghai SeeGen Photoelectric Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	06973786290641 [Primary]
GS1	16973786290235 [Package]; Package: Outer Package [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222261

FDA Product Code

• FBN: Choledochoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

On-Brand Devices [Flexible Video-Choledochoscope]

• 06973786290658: CHV-US110J-U
• 06973786290641: CHV-US100J-U