Nexpowder

Primary DI
08800038405332
Brand
Nexpowder
Company
NEXTBIOMEDICAL CO., LTD.
Model
NHS02
Device description
Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
Published
2023-10-05
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

Contact Domains#

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
K202929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202929000NexpowderNextbiomedical Co., Ltd.2022-09-16QAU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800038405339PackageGS15In Commercial Distribution
28800038405336PackageGS190In Commercial Distribution
08800038405332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880003840533918800038405339
2880003840533628800038405336
08800038405332088000384053328800038405332

GMDN Terms#

Term, Definition table
TermDefinition
Non-organic haemostatic agentA non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82324544822sales@nextbiomedical.co.kr

Regulatory Flags#

DUNS number
689845781
Device count
1
Kit
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800038405189NexpowderNHS032022-09-27
08800038405325NexpowderNHS012023-10-05
18800038405186NexpowderNHS032022-09-27

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
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
26972011720018EndoClotEndoClot Plus Co.,Ltd.QAU2022-03-15
00827002210493HemosprayCOOK INCORPORATEDQAU2018-05-25
00827002565722HemosprayCOOK INCORPORATEDQAU2018-05-25