| Primary Device ID | 06971176280364 |
| NIH Device Record Key | 60be3301-13f4-4b35-a53f-e4dc0203d6b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use Flexible Video Cystoscope |
| Version Model Number | PC200-S |
| 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 | 06971176280364 [Primary] |
| GS1 | 16971176280361 [Package] Package: box [10 Units] In Commercial Distribution |
| FAJ | Cystoscope 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 | 2022-12-12 |
| Device Publish Date | 2022-12-02 |
| 06971176280364 | This device is a sterile, single use video cystoscope intended to be used for endoscopic access |
| 06971176280357 | This device is a sterile, single use video cystoscope intended to be used for endoscopic access |
| 06971176280340 | This device is a sterile, single use video cystoscope intended to be used for endoscopic access |
| 06971176280333 | This device is a sterile, single use video cystoscope intended to be used for endoscopic access |