| Primary Device ID | 24251853902854 |
| NIH Device Record Key | 372b9319-633a-4163-aae7-e7ec715ee5d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Body Armor® PFA Walker Liner |
| Version Model Number | BAPFAL2 |
| Catalog Number | BAPFAL2 |
| 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 | 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 | 04251853902850 [Primary] |
| GS1 | 24251853902854 [Package] Contains: 04251853902850 Package: Case [12 Units] In Commercial Distribution |
| FZF | Splint, Extremity, Inflatable, External |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-23 |
| Device Publish Date | 2025-04-15 |
| 20609271000357 - KERRAPED PLUS™ All Purpose Boot | 2025-06-30 S Black Round-toe |
| 10609271000367 - KERRAPED PLUS™ All Purpose Boot | 2025-06-30 M Black Round-toe |
| 10609271000374 - KERRAPED PLUS™ All Purpose Boot | 2025-06-30 L Black Round-toe |
| 10609271000381 - KERRAPED PLUS™ All Purpose Boot | 2025-06-30 XL Black Round-toe |
| 14251853902826 - Body Armor® PFA Walker | 2025-04-23 Foot Stump Orthosis, Gray-Blue, M |
| 14251853902833 - Body Armor® PFA Walker | 2025-04-23 Foot Stump Orthosis, Gray-Blue, L |
| 14251853902840 - Body Armor® PFA Walker | 2025-04-23 Foot Stump Orthosis, Gray-Blue, XL |
| 24251853902854 - Body Armor® PFA Walker Liner | 2025-04-23Liner, Gray, M |
| 24251853902854 - Body Armor® PFA Walker Liner | 2025-04-23 Liner, Gray, M |