EndoClot

Primary DI
26972011720018
Brand
EndoClot
Company
EndoClot Plus Co.,Ltd.
Model
EPK2302-01
Device description
EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS
Published
2022-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QAUHemostatic Device For Endoscopic Gastrointestinal Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAUHemostatic Device For Endoscopic Gastrointestinal UseGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190677000EndoClotEndoclot Plus Co., Ltd.2021-01-29QAU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26972011720018PackageGS11In Commercial Distribution
36972011720015PackageGS114In Commercial Distribution
16972011720011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697201172001826972011720018
3697201172001536972011720015
1697201172001116972011720011

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, bioabsorbableA bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544357082
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972011720219EndoClot SIS-30SIS-302021-02-10
16972011720226EndoClot SIS-152021-06-23
16972011720240EndoClot SISSIS-30-01SIS-30-012021-11-16
16972011720257EndoClot SISSIS-15-01SIS-15-012021-11-16
16972011720516EndoClotEPAC-1T2022-03-18
26972011720513EndoClotEPAC-1T2022-03-18
16972011720011EndoClotEPK2302-012022-03-15
16972011720318EndoClot Air CompressorEPAC-22021-06-23
26972011720247EndoClot SISSIS-30-01SIS-30-012021-11-16
26972011720254EndoClot SISSIS-15-01SIS-15-012021-11-16
16972011720028EndoClot PHSEPK2303EPK2303-012021-06-23
16972011720035EndoClot PHSEPK2305EPK2305-012021-06-23
16972011720110EndoClot ApplicatorEA2302021-06-23
26972011720025EndoClot PHSEPK23032021-06-23
26972011720032EndoClot PHSEPK23052021-06-23
46972011720111EndoClot ApplicatorEA2302021-06-23
26972011720223EndoClot SIS-152021-06-23
26972011720315EndoClot Air CompressorEPAC-22021-06-23
26972011720216EndoClot SIS-30SIS-302021-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03664883000044PuraStat3-D MATRIX EUROPEQAU2026-02-01
04560436590354PuraStat3-D MATRIX EUROPEQAU2025-03-03
08800038405325NexpowderNEXTBIOMEDICAL CO., LTD.QAU2023-10-05
08800038405332NexpowderNEXTBIOMEDICAL CO., LTD.QAU2023-10-05
00860001820867PuraStat (1mL)3-D MATRIX INC.QAU2023-08-28
00860001820874PuraStat (3mL)3-D MATRIX INC.QAU2023-08-28
08800038405189NexpowderNEXTBIOMEDICAL CO., LTD.QAU2022-09-27
18800038405186NexpowderNEXTBIOMEDICAL CO., LTD.QAU2022-09-27
16972011720011EndoClotEndoClot Plus Co.,Ltd.QAU2022-03-15
00827002210493HemosprayCOOK INCORPORATEDQAU2018-05-25
00827002565722HemosprayCOOK INCORPORATEDQAU2018-05-25