| Primary Device ID | 00874485002749 |
| NIH Device Record Key | 12f04675-6721-47e1-97cc-ba24bfe4ff09 |
| Commercial Distribution Discontinuation | 2018-01-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Endoscopic Injection Needle |
| Version Model Number | 07-9005 |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 866-258-2182 |
| customercare@cogentixmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00874485002749 [Primary] |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-02 |
| Device Publish Date | 2016-09-23 |
| 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 |