| Primary Device ID | 00614464070549 |
| NIH Device Record Key | a72eb862-7d23-4091-bb5d-4eeca24d7c58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Therastep Gel Bunion Cushion Fr/Eng, 1/blister |
| Version Model Number | 7054 |
| Company DUNS | 056112948 |
| Company Name | Silipos Holding LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |