EndoClot

GUDID 26972011720018

EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS

EndoClot Plus Co.,Ltd.

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• Primary Device ID: 26972011720018
• NIH Device Record Key: 572be470-df59-4bec-8bdf-01b1b1c017c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoClot
• Version Model Number: EPK2302-01
• Company DUNS: 544357082
• Company Name: EndoClot Plus 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	16972011720011 [Primary]
GS1	26972011720018 [Package]; Contains: 16972011720011; Package: [1 Units]; In Commercial Distribution
GS1	36972011720015 [Package]; Package: [14 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190677

FDA Product Code

• QAU: Hemostatic Device For Endoscopic Gastrointestinal Use

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: 2022-03-23
• Device Publish Date: 2022-03-15

On-Brand Devices [EndoClot]

• 26972011720216: EndoClot Submucosal Injection System EndoClot® Submucosal Injection Agent is intended for use i
• 26972011720223: SIS-15
• 26972011720018: EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS
• 26972011720513: EndoClot® Air Compressor Connecting Tube