| 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 |
| 10827002346014 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002346939 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002347110 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002347783 - D.A.S.H. | 2024-08-07 D.A.S.H. Preloaded with Acrobat Wire Guide |
| 10827002347790 - D.A.S.H. | 2024-08-07 D.A.S.H. Preloaded with Acrobat Wire Guide |
| 10827002347806 - D.A.S.H. | 2024-08-07 D.A.S.H. Preloaded with Acrobat Wire Guide |
| 00827002216532 - COOK | 2024-05-23 Savary Gilliard Dilator Washer |
| 00827002560819 - COOK | 2024-05-23 Captura Serrated Jumbo Forcep - No Spike |