| Primary Device ID | 20609271000333 |
| NIH Device Record Key | a19522bb-eac7-4a04-bc6c-068613de289e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Health Design Canvas Cast Boot |
| Version Model Number | HD-CB-CV4 |
| Catalog Number | HD-CB-CV4 |
| 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 | 00609271000339 [Primary] |
| GS1 | 10609271000336 [Package] Contains: 00609271000339 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20609271000333 [Package] Contains: 00609271000339 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 |
| 20609271000340 | Extra-large Black |
| 20609271000333 | Large Black |
| 20609271000326 | Medium Black |
| 20609271000319 | Small Black |
| 20609271000302 | Extra-small Black |