Single Use Guidewire

GUDID 26970401813913

Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

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• Primary Device ID: 26970401813913
• NIH Device Record Key: 0caeb448-7ad0-4a87-b138-bd36fa5b81cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Guidewire
• Version Model Number: MD-S-GW3545
• Company DUNS: 544434963
• Company Name: Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	06970401813490 [Primary]
GS1	16970401813909 [Package]; Contains: 06970401813490; Package: Box [10 Units]; In Commercial Distribution
GS1	26970401813913 [Package]; Contains: 16970401813909; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• OCY: Endoscopic Guidewire, 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: 2019-04-01
• Device Publish Date: 2019-03-23

Devices Manufactured by Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

• 16970401815095 - Disposable Valve Sets: 2020-05-01
• 26970401814286 - Non-Rotatable Snares: 2019-10-31
• 26970401814262 - Non-Rotatable Snares: 2019-10-31
• 26970401814309 - Rotatable Snares: 2019-10-31
• 26970401813739 - Cleaning Brush: 2019-10-07
• 26970401813456 - Cleaning Brush: 2019-10-07
• 26970401813470 - Cleaning Brush: 2019-10-07
• 26970401813647 - Cleaning Brush: 2019-10-07