Innovex AnQing Medical

GUDID 06970034210116

Shanghai AnQing Medical Instrument Co., Ltd

Flexible video ureteroscope, single-use

• Primary Device ID: 06970034210116
• NIH Device Record Key: c6829ae0-fa4c-4875-850c-add5d2a0d850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innovex AnQing Medical
• Version Model Number: US31B-12
• Company DUNS: 544581269
• Company Name: Shanghai AnQing Medical Instrument 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970034210116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201293

FDA Product Code

• FGB: Ureteroscope 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: 2020-08-17
• Device Publish Date: 2020-08-07

On-Brand Devices [Innovex AnQing Medical]

• 06970034210123: US31A-12
• 06970034210116: US31B-12