| Primary Device ID | 30888937003247 |
| NIH Device Record Key | 65075d98-7480-4c50-b467-3a09b152d119 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CooperSurgical, Inc. |
| Version Model Number | 47-9005 |
| Company DUNS | 801895244 |
| Company Name | Coopersurgical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20888937003240 [Package] Contains: 60888937003248 Package: [5 Units] In Commercial Distribution |
| GS1 | 30888937003247 [Package] Contains: 60888937003248 Package: [20 Units] In Commercial Distribution |
| GS1 | 60888937003248 [Primary] |
| GBA | Catheter, Balloon Type |
| 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 | 2016-09-15 |
| 30888937003247 | Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French |
| 00888937011135 | Cervical Sizer |
| 00888937010015 | 16 Gauge Tip, 1 1/2" Needle, Curved |
| 00888937010008 | 16 Gauge Tip, 1 1/2" Needle |
| 00888937009996 | 14 Gauge Tip, 3" Needle, Curved, Long |
| 00888937009989 | 14 Gauge Tip, 3" Needle |
| 20888937003691 | 1X Macro Bipolar Insert (Long) |
| 20888937003684 | 1X Macro Bipolar Insert |