EndoClot SIS

Primary DI
16972011720240
Brand
EndoClot SIS
Company
EndoClot Plus Co.,Ltd.
Model
SIS-30-01
Catalog number
SIS-30-01
Device description
EndoClot Submucosal Injection System
Published
2021-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PLLSubmucosal Injection Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLLSubmucosal Injection AgentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191254000EndoClotEndoclot Plus Co., Ltd.2020-01-30PLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26972011720247PackageGS15In Commercial Distribution
36972011720244PackageGS110In Commercial Distribution
16972011720240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697201172024726972011720247
3697201172024436972011720244
1697201172024016972011720240

GMDN Terms#

Term, Definition table
TermDefinition
Submucosal lift solutionA sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g., polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. It is typically a gel-like emulsion (e.g., containing fats and/or salts), and may include a dye. This is a single-use device.

Regulatory Flags#

DUNS number
544357082
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972011720219EndoClot SIS-30SIS-302021-02-10
16972011720226EndoClot SIS-152021-06-23
16972011720257EndoClot SISSIS-15-01SIS-15-012021-11-16
16972011720516EndoClotEPAC-1T2022-03-18
26972011720513EndoClotEPAC-1T2022-03-18
16972011720011EndoClotEPK2302-012022-03-15
26972011720018EndoClotEPK2302-012022-03-15
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
00724995231866ASCENDO submucosal lifting agentUS EndoscopyPLL2024-09-02
10724995231863ASCENDO submucosal lifting agentTHE STANDARD CO.,LTD.PLL2024-09-02
08809380057473Blue EyeTHE STANDARD CO.,LTD.PLL2024-08-16
08809380057480Blue EyeThe Standard Co., Ltd.PLL2024-08-16
08809380050207Blue EyeTHE STANDARD CO.,LTD.PLL2023-07-19
08809380050214Blue EyeThe Standard Co., Ltd.PLL2023-07-19
00724995221614AscendoUS EndoscopyPLL2023-07-11
20724995221618AscendoUS EndoscopyPLL2023-07-11
06932503562515BlueBoost(TM) Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.PLL2023-06-28
06932503562522BlueBoost(TM) Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.PLL2023-06-28
16932503562512MTMicro-Tech (Nanjing) Co., Ltd.PLL2023-06-28
16932503562529MTMicro-Tech (Nanjing) Co., Ltd.PLL2023-06-28
04260206311003LiftUpOvesco Endoscopy AGPLL2022-08-22
04260206310990LiftUpOvesco Endoscopy AGPLL2022-08-22
04260206311355LiftUp KitOvesco Endoscopy AGPLL2022-08-22
05391530190466Eleview 5mLCOSMO TECHNOLOGIES LIMITEDPLL2022-04-01
05391530190459Eleview 5mLCOSMO TECHNOLOGIES LIMITEDPLL2022-04-01
16972011720257EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
26972011720247EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
26972011720254EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
16972011720226EndoClot EndoClot Plus Co.,Ltd.PLL2021-06-23
26972011720223EndoClot EndoClot Plus Co.,Ltd.PLL2021-06-23
05391530190367EleviewCOSMO TECHNOLOGIES LIMITEDPLL2021-03-28
05391530190008EleviewCOSMO TECHNOLOGIES LIMITEDPLL2021-03-28
00893029002243EverLiftGI Supply, Inc.PLL2021-02-18
00893029002229EverLiftGI Supply, Inc.PLL2021-02-18
10893029002240EverLiftGI Supply, Inc.PLL2021-02-18
16972011720219EndoClot EndoClot Plus Co.,Ltd.PLL2021-02-10
26972011720216EndoClot EndoClot Plus Co.,Ltd.PLL2021-02-10
05391530190053EleviewCOSMO TECHNOLOGIES LIMITEDPLL2019-12-19