Single-use Biliary Pancreaticobiliary Scope

GUDID 06970462546221

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video choledochoscope, single-use

• Primary Device ID: 06970462546221
• NIH Device Record Key: e200c163-1979-4995-a797-48ed56094058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Biliary Pancreaticobiliary Scope
• Version Model Number: CL-B
• Company DUNS: 403655303
• Company Name: Shenzhen HugeMed Medical Technical Development 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: true
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970462546221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241444

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: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [Single-use Biliary Pancreaticobiliary Scope]

• 06970462546221: CL-B
• 06970462546214: CL-A