EU－Scope

GUDID 06970034210130

Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed D

SHANGHAI ANQING MEDICAL INSTRUMENT CO.,LTD.

Flexible video ureteroscope, reusable

• Primary Device ID: 06970034210130
• NIH Device Record Key: 2eff9667-f5b2-4e68-9ec8-c402f580aaae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EU－Scope
• 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	06970034210130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180367

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-07
• Device Publish Date: 2018-08-22

Devices Manufactured by SHANGHAI ANQING MEDICAL INSTRUMENT CO.,LTD.

• 06970034210147 - DOS: 2019-03-08 The video processor is used with the Single Use Flexible Ureterorenoscope designed by ANQING during minimally invasive surgery.
• 06970034210345 - EU-Scope: 2019-03-08 Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be us
• 06970034210352 - DOS: 2019-03-08 The video processor is used with the Single Use Flexible Ureterorenoscope designed by ANQING during minimally invasive surgery.
• 06970034210130 - EU－Scope: 2019-03-07Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed D
• 06970034210130 - EU－Scope: 2019-03-07 Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be us