| 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 |