Innovex

GUDID 06970034210628

Shanghai AnQing Medical Instrument Co., Ltd

Flexible video ureterorenoscope, single-use

• Primary Device ID: 06970034210628
• NIH Device Record Key: 05353bfa-de11-49ff-8a84-e5ad3bdc51bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innovex
• Version Model Number: US31E-12-EU
• 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: false
• 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	06970034210628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222737

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: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [Innovex]

• 06970034210505: BS59H-28US
• 06970034210499: BS55H-24US
• 06970034210482: BS53H-22US
• 06970034210475: BS50H-20US
• 06970034210468: BS46H-17US
• 06970034210451: BS41H-12US
• 06970034210444: BS59H-28EU
• 06970034210437: BS55H-24EU
• 06970034210420: BS53H-22EU
• 06970034210413: BS50H-20EU
• 06970034210406: BS46H-17EU
• 06970034210390: BS41H-12EU
• 06970034210369: EOS-H-01
• 06970034210611: US31D-12-US
• 06970034210383: US31D-12-EU
• 06970034210635: US31E-12-US
• 06970034210628: US31E-12-EU
• 06970034210543: CY55H-24US
• 06970034210529: CY55H-24EU
• 06970034210536: CY50H-20US
• 06970034210512: CY50H-20EU
• 06970034210567: CS50H-20US
• 06970034210550: CS50H-20EU