EndoClot SIS-30

GUDID 26972011720216

EndoClot Submucosal Injection System EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

EndoClot Plus Co.,Ltd.

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• Primary Device ID: 26972011720216
• NIH Device Record Key: c7d8495c-eef3-4afb-ae11-8d26283b84d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoClot
• Version Model Number: SIS-30
• Catalog Number: SIS-30
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	16972011720219 [Primary]
GS1	26972011720216 [Package]; Contains: 16972011720219; Package: Shelf Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191254

FDA Product Code

• PLL: Submucosal Injection Agent

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: 2021-02-18
• Device Publish Date: 2021-02-10

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