| Primary Device ID | 00850008595035 |
| NIH Device Record Key | 17af5448-366c-4141-a382-3d959ce6bd5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cerene Cryotherapy Device |
| Version Model Number | FGS-7000 |
| Company DUNS | 963415513 |
| Company Name | CHANNEL MEDSYSTEMS, 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 | 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 | 00850008595035 [Primary] |
| MNB | Device, Thermal Ablation, Endometrial |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-31 |
| Device Publish Date | 2020-08-21 |
| 00850008595042 - Exhaust Collection Bag | 2023-04-14 Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device |
| 20850008595022 - Exhaust Collection Bag | 2020-08-31 Single exhaust collection bag in pouch |
| 00850008595035 - Cerene Cryotherapy Device | 2020-08-31 |
| 00850008595035 - Cerene Cryotherapy Device | 2020-08-31 |