| Primary Device ID | 10812261012619 | 
| NIH Device Record Key | 1e1d71fe-b9b1-45a6-aacd-470cec2d52b6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ARMADA | 
| Version Model Number | ARMADA Nottingham One Step Dilator 6F/12F | 
| Catalog Number | NOT 6/12 | 
| Company DUNS | 796354509 | 
| Company Name | ALLWIN MEDICAL DEVICES, INC. | 
| 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 | 
| 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 | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00812261012612 [Primary] | 
| GS1 | 10812261012619 [Package] Contains: 00812261012612 Package: Box Packing [10 Units] In Commercial Distribution | 
| EZN | Dilator, Catheter, Ureteral | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-08-08 | 
| Device Publish Date | 2023-07-31 | 
| 10812261012619 | ARMADA Nottingham One Step Dilator 6F/12F | 
| 10812261012602 | ARMADA Nottingham One Step Dilator 6F/10F |