Primary Device ID | 06923533809183 |
NIH Device Record Key | 521731c1-5627-40ba-a62f-b9612ac50cab |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PTA High Pressure Balloon Dilatation Catheter |
Version Model Number | HPA75-8080B6 |
Company DUNS | 544100893 |
Company Name | DK Medical Technology 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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06923533809183 [Primary] |
LIT | Catheter, Angioplasty, Peripheral, Transluminal |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-24 |
Device Publish Date | 2025-07-16 |
06923533809695 | HPA75-12060B7 |
06923533809510 | HPA75-10040B6 |
06923533808889 | HPA75-7040B5 |
06923533808643 | HPA75-6040B5 |
06923533808636 | HPA50-6040A5 |
06923533808391 | HPA50-5040A5 |
06923533808155 | HPA50-4040A5 |
06923533808162 | HPA75-4040B5 |
06923533809725 | HPA75-12080B7 |
06923533809664 | HPA75-12040B7 |
06923533809572 | HPA75-10080B6 |
06923533809428 | HPA75-9080B6 |
06923533809367 | HPA75-9040B6 |
06923533809213 | HPA75-80100B6 |
06923533809183 | HPA75-8080B6 |
06923533809121 | HPA75-8040B6 |
06923533808971 | HPA75-70100B5 |
06923533808940 | HPA75-7080B5 |
06923533808735 | HPA75-60100B5 |
06923533808704 | HPA75-6080B5 |
06923533808490 | HPA75-50100B5 |
06923533808469 | HPA75-5080B5 |
06923533808407 | HPA75-5040B5 |
06923533808223 | HPA75-4080B5 |