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.

Submucosal lift solution
Primary Device ID26972011720216
NIH Device Record Keyc7d8495c-eef3-4afb-ae11-8d26283b84d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoClot
Version Model NumberSIS-30
Catalog NumberSIS-30
Company DUNS544357082
Company NameEndoClot Plus Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS116972011720219 [Primary]
GS126972011720216 [Package]
Contains: 16972011720219
Package: Shelf Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLLSubmucosal Injection Agent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-18
Device Publish Date2021-02-10

On-Brand Devices [EndoClot ]

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

Trademark Results [EndoClot]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOCLOT
ENDOCLOT
97292080 not registered Live/Pending
EndoClot Plus, Inc.
2022-03-02
ENDOCLOT
ENDOCLOT
85322084 4412920 Live/Registered
EndoClot Plus, Inc.
2011-05-16

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