EndoClot SIS SIS-15-01

GUDID 26972011720254

EndoClot Submucosal Injection System

EndoClot Plus Co.,Ltd.

Submucosal lift solution

• 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