| 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 |