| Primary Device ID | 00827002572898 |
| NIH Device Record Key | 46861d1c-a71a-4ed6-bef5-957719e84e44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Huibregtse Katon |
| Version Model Number | G57289 |
| Catalog Number | ERCP-1-HKB-D |
| 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 | 00827002572898 [Primary] |
| ODD | Endoscopic retrograde cholangiopancreatography (ERCP) cannula |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2019-04-29 |
| 00827002214521 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002215009 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002217652 - COOK | 2024-04-03 CLASSIC ERCP CATHETER |
| 00827002218680 - COOK | 2024-04-03 HUIBREGTSE-KATON ERCP CATHETER |
| 00827002219656 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002220300 - COOK | 2024-04-03 CLASSIC ERCP CATHETER |
| 00827002220935 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002222267 - COOK | 2024-04-03 GLO-TIP II DOUBLE LUMEN ERCP CATHETER |