Nexpowder

Primary DI
18800038405186
Brand
Nexpowder
Company
NEXTBIOMEDICAL CO., LTD.
Model
NHS03
Device description
Nexpowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding.
Published
2022-09-27
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

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
18800038405186PackageGS15In Commercial Distribution
28800038405183PackageGS190In Commercial Distribution
08800038405189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880003840518618800038405186
2880003840518328800038405183
08800038405189088000384051898800038405189

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
689845781
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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
08800038405189NexpowderNHS032022-09-27
08800038405325NexpowderNHS012023-10-05
08800038405332NexpowderNHS022023-10-05

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
16972011720011EndoClotEndoClot Plus Co.,Ltd.QAU2022-03-15
26972011720018EndoClotEndoClot Plus Co.,Ltd.QAU2022-03-15
00827002210493HemosprayCOOK INCORPORATEDQAU2018-05-25
00827002565722HemosprayCOOK INCORPORATEDQAU2018-05-25