Sclerotherapy needle

GUDID 06974173021336

Zhejiang Chuangxiang Medical Technology Co., LTD.

General-purpose endoscopic needle, single-use

• Primary Device ID: 06974173021336
• NIH Device Record Key: 5499ee7e-e8e6-41d4-af09-a8a7dea046e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sclerotherapy needle
• Version Model Number: MD-B-SY-2412-2112
• 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	06974173021336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212668

FDA Product Code

• FBK: Endoscopic Injection Needle, 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: 2022-08-30
• Device Publish Date: 2022-08-22

On-Brand Devices [Sclerotherapy needle]

• 06970401815739: MD-A-SY-2423-2304
• 06970401817894: MD-A-SY-1812-2504
• 06970401817887: MD-A-SY-2420-2106
• 06970401817870: MD-A-SY-2420-2306
• 06970401817863: MD-A-SY-2420-2506
• 06970401817856: MD-A-SY-2420-2104
• 06970401817849: MD-A-SY-2420-2304
• 06970401815890: MD-A-SY-2412-2506
• 06970401815883: MD-A-SY-2412-2306
• 06970401815876: MD-A-SY-2412-2106
• 06970401815869: MD-A-SY-2418-2506
• 06970401815852: MD-A-SY-2418-2306
• 06970401815845: MD-A-SY-2418-2106
• 06970401815838: MD-A-SY-2423-2506
• 06970401815821: MD-A-SY-2423-2306
• 06970401815814: MD-A-SY-2423-2106
• 06970401815807: MD-A-SY-2412-2504
• 06970401815791: MD-A-SY-2412-2304
• 06970401815784: MD-A-SY-2412-2104
• 06970401815777: MD-A-SY-2418-2504
• 06970401815760: MD-A-SY-2418-2304
• 06970401815753: MD-A-SY-2418-2104
• 06970401815746: MD-A-SY-2423-2504
• 06970401815722: MD-A-SY-2423-2104
• 06970401813995: MD-A-SY-2418-2112
• 06970401813971: MD-A-SY-2418-2312
• 06970401813964: MD-A-SY-2418-2512
• 06970401813940: MD-A-SY-2418-2110
• 06970401813933: MD-A-SY-2418-2310
• 06970401813919: MD-A-SY-2418-2510
• 06970401813902: MD-A-SY-2418-2108
• 06970401813896: MD-A-SY-2418-2308
• 06970401813889: MD-A-SY-2418-2508
• 06970401813865: MD-A-SY-2412-2112
• 06970401813858: MD-A-SY-2412-2312
• 06970401813841: MD-A-SY-2412-2512
• 06970401813834: MD-A-SY-2412-2110
• 06970401813759: MD-A-SY-2412-2310
• 06970401813742: MD-A-SY-2412-2510
• 06970401813735: MD-A-SY-2412-2108
• 06970401813728: MD-A-SY-2412-2308
• 06970401813605: MD-A-SY-2412-2508
• 06970401813582: MD-A-SY-2423-1904
• 06970401813575: MD-A-SY-2420-1906
• 06970401813568: MD-A-SY-2420-1904
• 06970401813551: MD-A-SY-2418-1906
• 06970401813544: MD-A-SY-2418-1904
• 06970401813537: MD-A-SY-2412-1906
• 06970401813513: MD-A-SY-2412-1904
• 06970401813506: MD-A-SY-2420-2504