| Primary Device ID | 00607915112448 |
| NIH Device Record Key | 6c854a12-d542-4e9f-99f5-a26a443b489f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silhouette® Xtraflo Ureteral Stent |
| Version Model Number | B3854 |
| Company DUNS | 187129135 |
| Company Name | APPLIED MEDICAL RESOURCES CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Length | 20 Centimeter |
| Catheter Gauge | 6 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915112448 [Primary] |
| FAD | Stent, Ureteral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-07-13 |
| 00607915112493 | Temporary indwelling ureteral catheter to assist in urine drainage |
| 00607915112486 | Temporary indwelling ureteral catheter to assist in urine drainage |
| 00607915112479 | Temporary indwelling ureteral catheter to assist in urine drainage |
| 00607915112462 | Temporary indwelling ureteral catheter to assist in urine drainage. |
| 00607915112455 | Temporary indwelling ureteral catheter to assist in urine drainage. |
| 00607915112448 | Temporary indwelling ureteral catheter to assist in urine drainage. |
| 00607915112431 | Temporary indwelling ureteral catheter to assist in urine drainage. |
| 00607915112424 | Temporary indwelling ureteral catheter to assist in urine drainage. |
| 00607915112417 | Temporary indwelling ureteral catheter to assist in urine drainage. |
| 00607915112400 | Temporary indwelling ureteral catheter to assist in urine drainage. |
| 00607915112387 | Temporary indwelling ureteral catheter to assist in urine drainage. |