| Primary Device ID | 00827002165755 |
| NIH Device Record Key | eeede3a5-96f3-48c6-ab01-7d0d6bb5c217 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sholkoff |
| Version Model Number | G16575 |
| Catalog Number | J-SBH-683000 |
| 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 | 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 | 00827002165755 [Primary] |
| HES | INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (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 | 2016-09-24 |
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| 00827002607859 - COOK | 2025-07-30 |
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| 10827002496535 - Cotton-Leung Sof-Flex | 2025-03-03 Cotton-Leung Sof-Flex Biliary Stent |
| 00827002352674 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352681 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352698 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352704 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |