| Primary Device ID | 10609271000374 |
| NIH Device Record Key | dc57a207-e9f9-44d2-88f1-9222501c5266 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KERRAPED PLUS™ All Purpose Boot |
| Version Model Number | KPP3 |
| Catalog Number | KPP3 |
| Company DUNS | 343551081 |
| Company Name | Darco (Europe) GmbH |
| 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 | 00609271000377 [Primary] |
| GS1 | 10609271000374 [Package] Contains: 00609271000377 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20609271000371 [Package] Contains: 00609271000377 Package: Case [36 Units] In Commercial Distribution |
| KNP | ORTHOSIS, CORRECTIVE SHOE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-06-30 |
| Device Publish Date | 2023-02-13 |
| 10609271000381 | XL Black Round-toe |
| 10609271000374 | L Black Round-toe |
| 10609271000367 | M Black Round-toe |
| 20609271000357 | S Black Round-toe |