| Primary Device ID | 00614464011351 |
| NIH Device Record Key | ad7d57af-85d3-43e7-b389-b4edf69eb907 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Extra Comfort Ball of Foot Cushions, 1 Pair/Pkg |
| Version Model Number | 1135 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00614464011351 [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 | 2022-09-01 |
| Device Publish Date | 2022-08-24 |
| 00614464350054 - Malleolar Gel Sleeve, Bulk | 2022-09-06 |
| 00614464011184 - Corn Pad, Wide, 6pcs/bag | 2022-09-01 |
| 00614464011351 - Extra Comfort Ball of Foot Cushions, 1 Pair/Pkg | 2022-09-01 |
| 00614464011351 - Extra Comfort Ball of Foot Cushions, 1 Pair/Pkg | 2022-09-01 |
| 00614464016257 - Cushion SiloLiner, 6" x 14" | 2022-09-01 |
| 00614464040016 - Soft Zone Heel Spur w/Removable Plug, Small, 1pair/box | 2022-09-01 |
| 00614464040023 - Soft Zone Heel Spur w/Removable Plug, Medium, 1pair/box | 2022-09-01 |
| 00614464040030 - Soft Zone Heel Spur w/Removable Plug, Large, 1pair/box | 2022-09-01 |
| 00614464040054 - Softzone Low Profile Heel Cush, Medium, 1pair/box | 2022-09-01 |