| Primary Device ID | 00827002146945 | 
| NIH Device Record Key | e1e76da1-cfbd-4044-a7c0-66a8e67fd586 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cook-Cope Loop | 
| Version Model Number | G14694 | 
| Catalog Number | 085108 | 
| Company DUNS | 042823948 | 
| Company Name | COOK INCORPORATED | 
| 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 | true | 
| 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 | 00827002146945 [Primary] | 
| KOB | CATHETER, SUPRAPUBIC (AND ACCESSORIES) | 
| 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 | 2015-10-24 | 
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| 00827002152144 | Cook-Cope Loop Nephrostomy Catheter | 
| 00827002149175 | Cook-Cope Loop Nephrostomy Set | 
| 00827002147140 | Cook-Cope Loop Nephrostomy Set | 
| 00827002147058 | Cook-Cope Loop Nephrostomy Catheter | 
| 00827002146945 | Cook-Cope Loop Nephrostomy Catheter | 
| 00827002146587 | Cook-Cope Loop Nephrostomy Set | 
| 00827002142831 | Cook-Cope Loop Nephrostomy Catheter | 
| 00827002142824 | Cook-Cope Loop Nephrostomy Set | 
| 00827002270619 | Cook-Cope Loop Nephrostomy Catheter | 
| 00827002190986 | Cook-Cope Loop Nephrostomy Set | 
| 00827002168169 | Cook-Cope Loop Nephrostomy Catheter | 
| 00827002166585 | Cook-Cope Loop Nephrostomy Set | 
| 00827002159259 | Cook-Cope Loop Nephrostomy Set |