| Primary Device ID | 16936881134316 |
| NIH Device Record Key | 824bd0b2-4472-4602-9ff3-b07eaf18103f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ureteral Access Sheath |
| Version Model Number | U03B011228 |
| 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 | 06936881134319 [Primary] |
| GS1 | 16936881134316 [Package] Contains: 06936881134319 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 26936881134313 [Package] Package: Carton [10 Units] In Commercial Distribution |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-01 |
| Device Publish Date | 2024-04-23 |
| 16944932787688 | 12Fr×35cm |
| 16944932787671 | 10Fr×45cm |
| 16944932787664 | 14Fr×35cm |
| 16944932787657 | 10Fr×35cm |
| 16936881134408 | 14Fr×55cm |
| 16936881134392 | 14Fr×45cm |
| 16936881134378 | 14Fr×28cm |
| 16936881134361 | 14Fr×20cm |
| 16936881134354 | 14Fr×13cm |
| 16936881134347 | 12Fr×55cm |
| 16936881134330 | 12Fr×45cm |
| 16936881134316 | 12Fr×28cm |
| 16936881134309 | 12Fr×20cm |
| 16936881134293 | 12Fr×13cm |
| 16936881134286 | 10Fr×55cm |
| 16936881134255 | 10Fr×28cm |
| 16936881134248 | 10Fr×20cm |
| 16936881134231 | 10Fr×13cm |