| Primary Device ID | 10812261012985 |
| NIH Device Record Key | f8c69e9e-0b73-4492-863f-4c350eb45bc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Meatal Dilator Adult |
| Version Model Number | MDA |
| Catalog Number | MDA |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812261012988 [Primary] |
| GS1 | 10812261012985 [Package] Contains: 00812261012988 Package: [10 Units] In Commercial Distribution |
| KOE | Dilator, Urethral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-25 |
| Device Publish Date | 2020-09-17 |
| 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 |