| Primary Device ID | 00827002537453 |
| NIH Device Record Key | 0368ec6e-4505-4c06-b969-df145652a2dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soft-Pass |
| Version Model Number | G53745 |
| Catalog Number | J-SP-4415 |
| 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 | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002537453 [Primary] |
| MFD | CANNULA, INTRAUTERINE INSEMINATION |
| 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 |
| 00827002537453 | Soft-Pass Obturator |
| 00827002537446 | Soft-Pass Obturator |
| 00827002461727 | Echotip, Soft-Pass T.V.P. Embryo Transfer Catheter |
| 00827002303997 | Echotip, Soft-Pass Catheter Inner Catheter With Cannula |
| 00827002272064 | Echotip, Soft-Pass Embryo Transfer Catheter |
| 00827002191297 | Soft-Pass Obturator With Guide Catheter |
| 00827002190849 | Echotip, Soft-Pass Catheter Inner Catheter With Cannula |
| 00827002189553 | Echotip, Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula |
| 00827002189546 | Echotip, Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula |
| 00827002187344 | Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula |
| 00827002186583 | Echotip, Soft-Pass Embryo Transfer Catheter |
| 00827002186576 | Echotip, Soft-Pass Embryo Transfer Catheter |
| 00827002181908 | Soft-Pass Coaxial Insemination Catheter |
| 00827002181830 | Soft-Pass Insemination Catheter |
| 00827002179349 | Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula |
| 00827002179332 | Soft-Pass Embryo Transfer Catheter |
| 00827002179325 | Soft-Pass Embryo Transfer Catheter |
| 00827002179318 | Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula |
| 00827002179301 | Soft-Pass Embryo Transfer Catheter |
| 00827002179127 | Soft-Pass Insemination Catheter |
| 00827002179028 | Soft-Pass Embryo Transfer Catheter |
| 00827002176799 | Soft-Pass Catheter |
| 00827002176782 | Soft-Pass Catheter |
| 00827002176508 | Soft-Pass Catheter |
| 00827002176409 | Soft-Pass Catheter |
| 00827002173156 | Soft-Pass Catheter |