Single Use Ureteral Access Sheath

GUDID 06936534304076

Zhejiang Chuangxiang Medical Technology Co., LTD.

Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath

• Primary Device ID: 06936534304076
• NIH Device Record Key: 6fc1bf26-8687-4ba5-a8e5-e9649c334475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Ureteral Access Sheath
• Version Model Number: MD-A-AS-1045
• 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	06936534304076 [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