ASCENDO submucosal lifting agent

Primary DI
10724995231863
Brand
ASCENDO submucosal lifting agent
Company
THE STANDARD CO.,LTD.
Model
00712935
Published
2024-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K241591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241591000Blue EyeThe Standard Co., Ltd.2024-07-03PLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995231863PackageGS15Not in Commercial Distribution
50724995231861PackageGS112Not in Commercial Distribution
00724995231866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499523186310724995231863
5072499523186150724995231861
00724995231866007249952318667249952318660724995231866

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557812775
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
08809380050207Blue EyeTS-9052023-07-19
08809380057473Blue EyeTS-9102024-08-16
08809380059002Black EyeTS-2052019-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995231866ASCENDO submucosal lifting agentUS EndoscopyPLL2024-09-02
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
16972011720240EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
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