EndoClot SIS SIS-15-01

GUDID 26972011720254

EndoClot Submucosal Injection System

EndoClot Plus Co.,Ltd.

Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel

• Primary Device ID: 26972011720254
• NIH Device Record Key: 5cf4b479-a559-4193-81c7-f9871ce0b06d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoClot SIS
• Version Model Number: SIS-15-01
• Catalog Number: SIS-15-01
• 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	16972011720257 [Primary]
GS1	26972011720254 [Package]; Contains: 16972011720257; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	36972011720251 [Package]; Package: Shipping Carton [10 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: 2021-11-24
• Device Publish Date: 2021-11-16

On-Brand Devices [EndoClot SIS]

• 26972011720254: EndoClot Submucosal Injection System
• 26972011720247: EndoClot Submucosal Injection System