| Primary Device ID | 16971176282990 |
| NIH Device Record Key | 6b9ed041-764e-49a1-aa1a-3f01ccab51ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use Flexible Video Ureteroscope |
| Version Model Number | PU633A-R |
| Company DUNS | 544427443 |
| Company Name | Zhuhai Pusen Medical Technology Co, Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971176282993 [Primary] |
| GS1 | 16971176282990 [Package] Contains: 06971176282993 Package: carton [10 Units] In Commercial Distribution |
| FGB | Ureteroscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-21 |
| Device Publish Date | 2026-01-13 |
| 16971176282990 | This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc |
| 16971176282983 | This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc |
| 16971176282952 | This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc |
| 06971176282948 | This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc |