| Primary Device ID | GYNXCMR25101 |
| NIH Device Record Key | c02c37d8-99f3-45da-8953-0acfeb3def0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Carrera Loop Electrodes |
| Version Model Number | CMR-2510 |
| Company DUNS | 012997685 |
| Company Name | GYNEX CORPORATION |
| Device Count | 5 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | GYNXCMR25100 [Unit of Use] |
| HIBCC | GYNXCMR25101 [Primary] |
| HGI | Electrocautery, Gynecologic (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-04 |
| GYNXOCMR25151 | OCMR-2515 |
| GYNXOCMR25101 | OCMR-2510 |
| GYNXOCMR20151 | OCMR-2015 |
| GYNXOCMR20131 | OCMR-2013 |
| GYNXOCMR20101 | OCMR-2010 |
| GYNXOCMR20081 | OCMR-2008 |
| GYNXOCMR15121 | OCMR-1512 |
| GYNXOCMR10101 | OCMR-1010 |
| GYNXCMR25151 | CMR-2515 |
| GYNXCMR25101 | CMR-2510 |
| GYNXCMR20151 | CMR-2015 |
| GYNXCMR20131 | CMR-2013 |
| GYNXCMR20101 | CMR-2010 |
| GYNXCMR20081 | CMR-2008 |
| GYNXCMR15121 | CMR-1512 |
| GYNXCMR15081 | CMR-1508 |
| GYNXCMR10101 | CMR-1010 |
| GYNXCMR10071 | CMR-1007 |
| GYNXCMB2521 | CMB-2-5-2 |