| Primary Device ID | 00827002165717 | 
| NIH Device Record Key | 62af5de4-1c83-4f78-bbb6-72875d674c89 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Silber | 
| Version Model Number | G16571 | 
| Catalog Number | J-SAC-400300 | 
| 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 | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 | 
| sharedservices@cookmedical.com | |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00827002165717 [Primary] | 
| KDH | CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION | 
| 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 | 2016-11-04 | 
| 00827002152847 | Silber Aspiration Catheter | 
| 00827002165717 | Silber Aspiration Catheter | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SILBER  90387549  not registered Live/Pending | Bernabe Perez 2020-12-16 | 
|  SILBER  90387549  not registered Live/Pending | Silvia Chavez 2020-12-16 |