Single Use Ureteral Access Sheath

GUDID 06936534303994

Zhejiang Chuangxiang Medical Technology Co., LTD.

Ureteral sheath

• Primary Device ID: 06936534303994
• NIH Device Record Key: d470a488-334f-49e0-9a49-a98cfd886147
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Ureteral Access Sheath
• Version Model Number: MD-A-AS-1225
• Company DUNS: 544434963
• Company Name: Zhejiang Chuangxiang Medical Technology 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: false
• 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	06936534303994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220065

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

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: 2023-06-01
• Device Publish Date: 2023-05-24

On-Brand Devices [Single Use Ureteral Access Sheath]

• 06936534303956: MD-A-AS-1445
• 06936534303949: MD-A-AS-1435
• 06936534303932: MD-A-AS-1425
• 06936534303925: MD-A-AS-1420
• 06936534303918: MD-A-AS-1416
• 06936534304267: MD-B-AS-1055
• 06936534304250: MD-B-AS-1045
• 06936534304243: MD-B-AS-1035
• 06936534304236: MD-B-AS-1025
• 06936534304229: MD-B-AS-1020
• 06936534304212: MD-B-AS-1016
• 06936534304205: MD-B-AS-1255
• 06936534304199: MD-B-AS-1245
• 06936534304182: MD-B-AS-1235
• 06936534304175: MD-B-AS-1225
• 06936534304168: MD-B-AS-1220
• 06936534304151: MD-B-AS-1216
• 06936534304144: MD-B-AS-1455
• 06936534304137: MD-B-AS-1445
• 06936534304120: MD-B-AS-1435
• 06936534304113: MD-B-AS-1425
• 06936534304106: MD-B-AS-1420
• 06936534304090: MD-B-AS-1416
• 06936534304083: MD-A-AS-1055
• 06936534304076: MD-A-AS-1045
• 06936534304069: MD-A-AS-1035
• 06936534304052: MD-A-AS-1025
• 06936534304045: MD-A-AS-1020
• 06936534304038: MD-A-AS-1016
• 06936534304021: MD-A-AS-1255
• 06936534304014: MD-A-AS-1245
• 06936534304007: MD-A-AS-1235
• 06936534303994: MD-A-AS-1225
• 06936534303987: MD-A-AS-1220
• 06936534303970: MD-A-AS-1216