| Primary Device ID | 20609271000289 |
| NIH Device Record Key | 46e4e705-fccf-4236-8052-f67fae801b40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KERRAPED™ All Purpose Boot |
| Version Model Number | KP4B |
| Catalog Number | KP4B |
| 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 | true |
| 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 | 00609271000285 [Primary] |
| GS1 | 10609271000282 [Package] Contains: 00609271000285 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20609271000289 [Package] Contains: 00609271000285 Package: Case [36 Units] In Commercial Distribution |
| KNP | ORTHOSIS, CORRECTIVE SHOE |
| 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 |
| 20609271000289 | XL Black Round-toe |
| 20609271000272 | L Black Round-toe |
| 10609271000268 | M Black Round-toe |
| 10609271000251 | S Black Round-toe |