| Primary Device ID | 10888853002962 |
| NIH Device Record Key | 08da1bf6-d7ae-4cd9-b78e-7de6986a1ea6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Freeze Away 8ct |
| Version Model Number | 90000335 |
| Company DUNS | 117174744 |
| Company Name | SCHOLL'S WELLNESS COMPANY LLC |
| Device Count | 8 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com | |
| Phone | 19738015515 |
| alex.terranova@drscholls.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888853002965 [Unit of Use] |
| GS1 | 10888853002962 [Primary] |
| GEH | Unit, Cryosurgical, Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-19 |
| Device Publish Date | 2022-07-11 |