| Primary Device ID | 10609271952604 |
| NIH Device Record Key | 28d59ce1-935c-4240-bb8d-4a74b053d387 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MECRON Torso Sonderanfertigung |
| Version Model Number | S4200 |
| Catalog Number | S4200 |
| 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 | 00609271952607 [Primary] |
| GS1 | 10609271952604 [Package] Contains: 00609271952607 Package: Box [12 Units] In Commercial Distribution |
| IPX | ORTHOSIS, RIB FRACTURE, SOFT |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-22 |
| Device Publish Date | 2023-02-14 |
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| 10609271999289 - Duo™ Pro Wound Care shoe | 2024-12-23 black (small) |
| 20609271999293 - Duo™ Pro Wound Care shoe | 2024-12-23 black (medium) |
| 10609271999302 - Duo™ Pro Wound Care shoe | 2024-12-23 black (large) |
| 10609271999319 - Duo™ Pro Wound Care shoe | 2024-12-23 black (extra-large) |
| 20609271999323 - Duo™ Pro Wound Care shoe | 2024-12-23 black (2X-large) |
| 20609271040025 - Body Armor® Stirrup Walker | 2023-11-10 Tall, white (medium) |
| 10609271040035 - Body Armor® Stirrup Walker | 2023-11-10 Tall, white (large) |