Single Use Hemoclip

GUDID 06970401811212

Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

Gastrointestinal endoscopic clip, short-term

• Primary Device ID: 06970401811212
• NIH Device Record Key: 8e8c101d-86ea-4288-b3e2-2075a71b310a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Hemoclip
• Version Model Number: MD-G-HR-230-12-135-Y
• Company DUNS: 544434963
• Company Name: Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06970401811212 [Primary]
GS1	16970401813220 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	26970401813234 [Package]; Contains: 16970401813220; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172762
• Premarket Notification: K212669

FDA Product Code

• PKL: Hemostatic Metal Clip For The Gi Tract

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-25
• Device Publish Date: 2018-07-06

On-Brand Devices [Single Use Hemoclip]

• 26970401813890: MD-C-HR-270-13-135-Y
• 26970401813715: MD-G-HR-230-12-135-N
• 26970401813197: MD-C-HR-230-13-135-Y
• 26970401813296: MD-G-HR-195-12-135-Y
• 06970401811212: MD-G-HR-230-12-135-Y
• 26970401813166: MD-L-HR-230-15-135-Y
• 26970401812862: MD-L-HR-270-15-135-Y