| Primary Device ID | 16936881134460 |
| NIH Device Record Key | 4957a605-0ba7-4c53-82a1-3720530ab895 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PVC Urethral Catheter |
| Version Model Number | F01D02161F |
| Company DUNS | 544811862 |
| Company Name | Well Lead Medical Co.,Ltd |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06936881134463 [Primary] |
| GS1 | 16936881134460 [Package] Contains: 06936881134463 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 26936881134467 [Package] Package: Carton [6 Units] In Commercial Distribution |
| EZD | Catheter, Straight |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2024-04-29 |
| 16936881134606 | Male(standard), 1-way 24Fr |
| 16936881134590 | Male(standard), 1-way 22Fr |
| 16936881134583 | Male(standard), 1-way 20Fr |
| 16936881134576 | Male(standard), 1-way 18Fr |
| 16936881134569 | Male(standard), 1-way 16Fr |
| 16936881134552 | Male(standard), 1-way 14Fr |
| 16936881134545 | Male(standard), 1-way 12Fr |
| 16936881134538 | Pediatric, 1-way 10Fr |
| 16936881134521 | Pediatric, 1-way 8Fr |
| 16936881134514 | Pediatric, 1-way 6Fr |
| 16936881134507 | Female, 1-way 24Fr |
| 16936881134491 | Female, 1-way 22Fr |
| 16936881134484 | Female, 1-way 20Fr |
| 16936881134477 | Female, 1-way 18Fr |
| 16936881134460 | Female, 1-way 16Fr |
| 16936881134453 | Female, 1-way 14Fr |
| 16936881134446 | Female, 1-way 12Fr |