| Primary Device ID | 00082147000853 |
| NIH Device Record Key | c40bb957-477b-4c99-bc66-95a65ca19f00 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAPAD COMF-ORTHOTIC WOOL FELT FULL LENGTH INSOLE |
| Version Model Number | WOMENS 10 1/2 - 11 1/2 |
| Catalog Number | FCOWXL |
| Company DUNS | 004510525 |
| Company Name | HAPAD INC |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00082147000853 [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 | 2023-08-08 |
| Device Publish Date | 2023-07-31 |
| 00082147000877 | MENS 5-6 1/2 |
| 00082147000860 | WOMENS 4 1/2 - 5/12 |
| 00082147000853 | WOMENS 10 1/2 - 11 1/2 |
| 00082147000846 | WOMENS 6-7 |
| 00082147000839 | WOMENS 7 1/2 - 81/2 |
| 00082147000822 | WOMENS 9-10 |
| 00082147000815 | MENS 7-8 1/2 EEE |
| 00082147000808 | PEDIATRIC SIZE 10-11 1/2 |
| 00082147000785 | PEDIATRIC SIZE 1-2 1/2 |
| 00082147000778 | PEDIATRIC SIZE 3-4 1/2 |
| 00082147000761 | MENS 15+ |
| 00082147000754 | MENS 13-14 1/2 |
| 00082147000747 | MENS 7-8 /2 |
| 00082147000730 | MENS 10-11 |
| 00082147000723 | MENS 9-9 1/2 |
| 00082147000716 | MENS 11 1/2- 12 1/2 |
| 00082147000709 | MENS 10-11 EEE |
| 00082147000693 | MENS 9-9 1/2 EEE |
| 00008214700792 | PEDIATRIC SIZE 12- 13 1/2 |
| 00082147000792 | PEDIATRIC SIZE 12-13 1/2 |