| Primary Device ID | 00827002215351 |
| NIH Device Record Key | c9f6fbeb-23ba-4b09-8d24-e10007fd3252 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soehendra |
| Version Model Number | G21535 |
| Catalog Number | SSR-11.5 |
| Company DUNS | 079720472 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002215351 [Primary] |
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2015-11-03 |
| 00827002508002 | Soehendra Biliary Dilation Catheter |
| 00827002222052 | Soehendra Stent Retriever |
| 00827002220621 | Soehendra Biliary Dilation Catheter |
| 00827002220461 | Soehendra Biliary Dilation Catheter |
| 00827002219373 | Soehendra Stent Retriever |
| 00827002219342 | Soehendra Stent Retriever |
| 00827002218604 | Soehendra Lithotriptor Handle |
| 00827002217324 | Soehendra Billroth II Sphincterotome |
| 00827002217294 | Soehendra Biliary Dilation Catheter |
| 00827002216617 | Soehendra Stent Retriever |
| 00827002216044 | Soehendra Lithotripsy Cable |
| 00827002215764 | Soehendra Biliary Dilation Catheter |
| 00827002215733 | Soehendra Biliary Dilation Catheter |
| 00827002215719 | Soehendra Biliary Dilation Catheter |
| 00827002215689 | Soehendra Biliary Dilation Catheter |
| 00827002215351 | Soehendra Stent Retriever |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOEHENDRA 74232968 1800616 Live/Registered |
COOK MEDICAL TECHNOLOGIES LLC 1991-12-23 |