| Primary Device ID | 10609271000442 |
| NIH Device Record Key | 1aeddf75-c3e3-4de6-b082-c92ae1e39ec9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Health Design Polycast Cast Boot |
| Version Model Number | HD-CB-PC5 |
| Catalog Number | HD-CB-PC5 |
| 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 | 00609271000445 [Primary] |
| GS1 | 10609271000442 [Package] Contains: 00609271000445 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20609271000449 [Package] Contains: 00609271000445 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 |
| 20609271000456 | Extra-large Black |
| 10609271000442 | Large Black |
| 10609271000435 | Medium Black |
| 20609271000425 | Small Black |
| 20609271000418 | Extra-small Black |
| 20609271000401 | Pediatric Black |