| Primary Device ID | G0648317270022880 |
| NIH Device Record Key | 851db02c-20a7-434e-8267-69cee6e1fd55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GAITKEEPER Cast Shoe |
| Version Model Number | 831727002288 |
| Company DUNS | 116685742 |
| Company Name | Walgreen Health Solutions, 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 | true |
| 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 |
|---|---|
| HIBCC | G0648317270022880 [Primary] |
| IPG | Shoe, Cast |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-06-16 |
| G0648317270027900 | Ankle High Square Toe Shoe - X-Large |
| G0648317270027830 | Ankle High Square Toe Shoe - Large |
| G0648317270027760 | Ankle High Square Toe Shoe - Medium |
| G0648317270027690 | Ankle High Square Toe Shoe - Small |
| G0648317270027520 | High Square Toe Shoe X-Small |
| G0648317270026600 | GAITKEEPER® Round Toe Cast Shoe - X-Large |
| G0648317270022950 | GAITKEEPER® Round Toe Cast Shoe - Large |
| G0648317270022880 | GAITKEEPER® Round Toe Cast Shoe - Medium |
| G0648317270022710 | GAITKEEPER® Round Toe Cast Shoe - Small |
| G0648317270022640 | GAITKEEPER® Round Toe Cast Shoe - XSmall |