Nexpowder
GUDID 08800038405332
Nexpowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
Non-organic haemostatic agent| Primary Device ID | 08800038405332 |
| NIH Device Record Key | c64a9a2c-6e60-4c05-a099-978f4ee5ef23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nexpowder |
| Version Model Number | NHS02 |
| Company DUNS | 689845781 |
| Company Name | NEXTBIOMEDICAL CO., LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800038405332 [Primary] |
| GS1 | 18800038405339 [Package] Package: Box [5 Units] In Commercial Distribution |
| GS1 | 28800038405336 [Package] Contains: 18800038405339 Package: Box [90 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202929
FDA Product Code
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-13 |
| Device Publish Date | 2023-10-05 |
On-Brand Devices [Nexpowder]
| 18800038405186 | Nexpowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding. |
| 08800038405332 | Nexpowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding. |
| 08800038405325 | expowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding. |
Trademark Results [Nexpowder]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEXPOWDER 79295194 not registered Live/Pending |
NEXTBIOMEDICAL CO., LTD. 2020-08-27 |
 NEXPOWDER 79283530 not registered Live/Pending |
NEXTBIOMEDICAL CO., LTD. 2020-03-18 |
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