| Primary Device ID | H206011051 |
| NIH Device Record Key | 970cf7bc-2bdc-430b-8089-f49346700b05 |
| Commercial Distribution Discontinuation | 2018-02-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GYNECARE THERMACHOICE |
| Version Model Number | 01105 |
| Catalog Number | 01105 |
| Company DUNS | 002144145 |
| Company Name | ETHICON INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20705031000886 [Primary] |
| HIBCC | H206011051 [Secondary] |
| MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-09-20 |
| H206TC0131 | Uterine Balloon Therapy System with Fluid Circulation |
| H206011051 | Thermal Balloon Ablation Umbilical Cable. For use only with GYNECARE THERMACHOICE TM UBT System |
| 20705031050737 | With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For u |