| Primary Device ID | 10827002186641 |
| NIH Device Record Key | b9d503e9-642b-4713-8a18-84f2b8495112 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Goldstein |
| Version Model Number | G18664 |
| Catalog Number | J-GSHC-522620 |
| 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 | 00827002186644 [Primary] |
| GS1 | 10827002186641 [Package] Contains: 00827002186644 Package: [10 Units] In Commercial Distribution |
| LKF | Cannula, manipulator/injector, uterine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-17 |
| Device Publish Date | 2016-09-24 |
| 10827002190129 | Goldstein Sonohysterography Catheter |
| 10827002186658 | Goldstein Sonohysterography Catheter |
| 10827002186641 | Goldstein Sonohysterography Catheter |
| 10827002171494 | Goldstein Sonohysterography Catheter |
| 10827002461908 | Goldstein Sonobiopsy Catheter |