EndoClot Applicator

GUDID 46972011720111

EndoClot Plus Co.,Ltd.

Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Primary Device ID46972011720111
NIH Device Record Keyf3258f82-9a8a-4878-918f-df68728bde74
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoClot Applicator
Version Model NumberEA230
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 Kitfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS116972011720110 [Primary]
GS146972011720111 [Package]
Contains: 16972011720110
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-01
Device Publish Date2021-06-23

Devices Manufactured by EndoClot Plus Co.,Ltd.

26972011720513 - EndoClot2022-03-28 EndoClot® Air Compressor Connecting Tube
26972011720018 - EndoClot2022-03-23 EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS
26972011720247 - EndoClot SIS2021-11-24 EndoClot Submucosal Injection System
26972011720254 - EndoClot SIS2021-11-24 EndoClot Submucosal Injection System
26972011720025 - EndoClot PHS2021-07-01
26972011720032 - EndoClot PHS2021-07-01
46972011720111 - EndoClot Applicator2021-07-01
46972011720111 - EndoClot Applicator2021-07-01
26972011720223 - EndoClot 2021-07-01

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