| Primary Device ID | 10609271000503 |
| NIH Device Record Key | 98fcf8bb-d5c6-447b-8c58-75972712f68f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Health Design Low Profile Cast Boot |
| Version Model Number | HD-CB-TP1 |
| Catalog Number | HD-CB-TP1 |
| Company DUNS | 184231298 |
| Company Name | DARCO INTERNATIONAL, 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00609271000506 [Primary] |
| GS1 | 10609271000503 [Package] Contains: 00609271000506 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20609271000500 [Package] Contains: 00609271000506 Package: Case [36 Units] In Commercial Distribution |
| IPG | SHOE, CAST |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-16 |
| Device Publish Date | 2023-02-08 |
| 10609271000558 | Extra-Large Black |
| 20609271000548 | Large Black |
| 10609271000534 | Medium/Large Black |
| 20609271000524 | Medium Black |
| 20609271000517 | Small/Medium Black |
| 10609271000503 | Small Black |