| Primary Device ID | 10827002140537 |
| NIH Device Record Key | b38c5578-dd6b-4989-a231-188a8804749d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Round Tip |
| Version Model Number | G14053 |
| Catalog Number | 024206 |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002140530 [Primary] |
| GS1 | 10827002140537 [Package] Contains: 00827002140530 Package: [10 Units] In Commercial Distribution |
| GBL | CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-09-24 |
| 00827002151727 | Round Tip Ureteral Catheter (Left) |
| 00827002146860 | Round Tip Ureteral Catheter (Left) |
| 00827002145931 | Round Tip Ureteral Catheter (Right) |
| 10827002140537 | Round Tip Ureteral Catheter (Left) |
| 00827002172371 | Round Tip Ureteral Catheter (Left) |