| Primary Device ID | 08431082070841 |
| NIH Device Record Key | 99d7951f-6d6f-4370-acd7-4221bfb7f039 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comforsil |
| Version Model Number | CC218S |
| Catalog Number | 800398 |
| Company DUNS | 462011560 |
| Company Name | PRIM S.A. |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08431082070841 [Primary] |
| KYS | Insoles, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-18 |
| Device Publish Date | 2024-03-08 |
| 08431082070902 | Nocturnal "Hallux Valgus" bunion corrector, pair |
| 08431082070896 | Cuttable adhesive felt sheet |
| 08431082070858 | Thick toe separator, Silicone |
| 08431082070841 | Thick toe separator, Silicone |
| 08431082070834 | Toe separator, extra fine, silicone |
| 08431082070827 | Toe separator, extra fine, silicone |
| 08431082070810 | Toe separator, extra fine, silicone |
| 08431082070773 | Protective tube with internal Gel coating. Mesh fabric 1.5 cm |
| 08431082070391 | Thick toe separator, Silicone |
| 08431082070216 | Silicone insoles with anti-impact discharge |
| 08431082070209 | Silicone insoles with anti-impact discharge |
| 08431082070193 | Silicone insoles with anti-impact discharge |
| 08431082070186 | Silicone insoles with anti-impact discharge |