Single Use Cytology Brush

GUDID 06970401810833

Zhejiang Chuangxiang Medical Technology Co., LTD.

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 06970401810833
• NIH Device Record Key: 03637a2c-e479-436b-9ea1-400bda73987e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Cytology Brush
• Version Model Number: MD-L-CB-3716-5010
• 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	06970401810833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220063

FDA Product Code

• FDX: Endoscopic Cytology Brush

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: 2023-05-26
• Device Publish Date: 2023-05-18

On-Brand Devices [Single Use Cytology Brush]

• 06970401810895: MD-U-CB-3723-6008
• 06970401810888: MD-U-CB-2820-6008
• 06970401810871: MD-U-CB-2016-4008
• 06970401810864: MD-U-CB-2012-4008
• 06970401810857: MD-L-CB-3723-5010
• 06970401810840: MD-L-CB-3720-5010
• 06970401810833: MD-L-CB-3716-5010
• 06970401810826: MD-L-CB-2823-3010
• 06970401810819: MD-L-CB-2820-3010
• 06970401810802: MD-L-CB-2816-3010
• 06970401810796: MD-L-CB-2023-2010
• 06970401810789: MD-L-CB-2020-2010
• 06970401810772: MD-L-CB-2016-2010
• 06970401810765: MD-L-CB-2012-5010
• 06970401810758: MD-L-CB-2012-3010
• 06970401810741: MD-L-CB-2012-2010
• 06970401810734: MD-L-CB-2012-1210
• 06970401810727: MD-L-CB-2007-2010
• 06970401810710: MD-L-CB-1212-2006
• 06970401810703: MD-L-CB-1210-1006
• 06970401810697: MD-L-CB-1207-1006