| Primary Device ID | 16936881133395 |
| NIH Device Record Key | de4bad4c-27fc-4493-8fcd-de6fbf8e4895 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wellead Male External Catheter |
| Version Model Number | F03A013010 |
| Company DUNS | 544811862 |
| Company Name | Well Lead Medical Co.,Ltd |
| 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 | 06936881133398 [Primary] |
| GS1 | 16936881133395 [Package] Contains: 06936881133398 Package: Box [30 Units] In Commercial Distribution |
| GS1 | 26936881133392 [Package] Package: Carton [10 Units] In Commercial Distribution |
| EXJ | Device, Incontinence, Urosheath Type, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-19 |
| Device Publish Date | 2023-07-11 |
| 16944932730752 | Type III 41mm |
| 16944932730745 | Type III 36mm |
| 16944932730738 | Type III 32mm |
| 16944932730721 | Type III 29mm |
| 16944932730714 | Type III 25mm |
| 16944932725574 | Type II 41mm |
| 16936881133524 | Type III 30mm |
| 16936881133500 | Type III 28mm |
| 16944932725567 | Type II 36mm |
| 16944932725550 | Type II 32mm |
| 16944932725543 | Type II 29mm |
| 16944932725536 | Type II 25mm |
| 16944932725529 | Type I 41mm |
| 16944932725512 | Type I 36mm |
| 16944932725505 | Type I 32mm |
| 16944932725499 | Type I 29mm |
| 16944932725482 | Type I 25mm |
| 16936881133456 | Type II 30mm |
| 16936881133432 | Type II 28mm |
| 16936881133395 | Type I 30mm |
| 16936881133388 | Type I 28mm |