| Device Type ID | 1701 |
| Device Name | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile |
| Regulation Description | Urine Collector And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EYT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1701 |
| Device | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile |
| Product Code | EYT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |