| Primary Device ID | 00827002494077 |
| NIH Device Record Key | c4852693-ece3-4e7e-a505-f5ec1d2e2ac7 |
| Commercial Distribution Discontinuation | 2019-09-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Soft-Trans |
| Version Model Number | G49407 |
| Catalog Number | K-SOFT-4014 |
| 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 | 00827002494077 [Primary] |
| MQF | CATHETER, ASSISTED REPRODUCTION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-05 |
| Device Publish Date | 2016-09-24 |
| 00827002033627 | Soft-Trans Guide Catheter |
| 00827002494091 | Soft-Trans Trial Cannulation Catheter |
| 00827002494084 | Soft-Trans Malleable Obturator |
| 00827002494077 | Soft-Trans Malleable Obturator |
| 00827002494060 | Soft-Trans Malleable Obturator |
| 00827002327559 | Soft-Trans Embryo Transfer Catheter |
| 00827002296398 | Soft-Trans Embryo Transfer Catheter |
| 00827002296350 | Soft-Trans Embryo Transfer Catheter With Gold Tip |
| 00827002296343 | Soft-Trans Guide Catheter |
| 00827002267794 | Soft-Trans Embryo Transfer Catheter With Gold Tip |
| 00827002266698 | Soft-Trans Embryo Transfer Catheter |
| 00827002266629 | Soft-Trans Embryo Transfer Catheter |
| 00827002266407 | Soft-Trans Embryo Transfer Catheter |
| 00827002261792 | Soft-Trans Trial Catheter With Guide Catheter |
| 00827002261518 | Soft-Trans Embryo Transfer Catheter |
| 00827002204812 | Soft-Trans Guide Catheter |
| 00827002203709 | Soft-Trans Embryo Transfer Catheter |
| 00827002203129 | Soft-Trans Embryo Transfer Catheter |
| 00827002201972 | Soft-Trans Embryo Transfer Catheter |
| 00827002201958 | Soft-Trans Embryo Transfer Catheter |