| Primary Device ID | 00874485001599 |
| NIH Device Record Key | f576162a-1a8b-4aef-b00b-afe6196d4636 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flexible Fiberoptic Cystoscope |
| Version Model Number | CST-4000 |
| Catalog Number | 08-4201 |
| Company DUNS | 780024725 |
| Company Name | COGENTIX MEDICAL, INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 866-258-2182 |
| customercare@cogentixmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00874485001599 [Primary] |
| HIH | Hysteroscope (And Accessories) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00874485001599]
High-level Disinfectant
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-22 |
| 00874485002954 - Flexible Fiber Laryngoscope, Standard Set Reconditioned | 2019-07-02 Reconditioned |
| 00874485000844 - Flexible Video Esophagoscope (NTSC) | 2019-07-02 |
| 00874485000868 - Flexible Video Laryngoscope (NTSC) | 2019-07-02 |
| 00874485000943 - Video Processor | 2019-07-02 Digital Processing Unit with Integrated LCD Display and Air Insufflation |
| 00874485001360 - Flexible Fiber Laryngoscope, Standard Set | 2019-07-02 |
| 00874485001544 - Flexible Fiber Bronchoscope | 2019-07-02 |
| 00874485001629 - Flexible Fiber Laryngoscope, Standard Set | 2019-07-02 |
| 00874485002367 - Flexible Video Bronchoscope (NTSC) | 2019-07-02 |