| Primary Device ID | 00812261016689 |
| NIH Device Record Key | 4f8fdb7f-9f83-4395-b2e4-a93f949b36ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYSTERO CATH |
| Version Model Number | HYSTERO CATH Hysterosalpingography Catheter Closed |
| Catalog Number | HC-HSG7 |
| Company DUNS | 796354509 |
| Company Name | ALLWIN MEDICAL DEVICES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com | |
| Phone | 714-572-1709 |
| info@allwinmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812261016689 [Primary] |
| GS1 | 10812261016686 [Package] Package: Box Packing [5 Units] In Commercial Distribution |
| LKF | Cannula, Manipulator/Injector, Uterine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-07 |
| Device Publish Date | 2023-07-28 |
| 00812261016597 - ASPI | 2024-02-16 ASPI Aspiration Needle 22G,30cm |
| 10819374020401 - Krait | 2023-08-09 Krait Ureteral Catheter Open Tip 4F, 70cm |
| 10819374020418 - Krait | 2023-08-09 Krait Ureteral Catheter Open Tip 3F, 70cm |
| 10819374022382 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 3F, 70cm |
| 10819374022399 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 4F, 70cm |
| 10819374022405 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 5F, 70cm |
| 10819374023174 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 6F, 70cm |
| 10819374024379 - Krait | 2023-08-09 Krait Ureteral Catheter Open Tip 7F, 70cm |