| Primary Device ID | 00026072012208 |
| NIH Device Record Key | 4a4f0997-edf5-414c-b4a3-597ce2ecf07c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SC |
| Version Model Number | S511 |
| Company DUNS | 119066872 |
| Company Name | Allied Medical, LLC |
| 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 | false |
| 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 | 00026072012208 [Primary] |
| FYH | Splint, Extremity, Noninflatable, External, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-17 |
| Device Publish Date | 2024-05-09 |
| 00026072022900 | 4 MINI SPLINT |
| 00026072022894 | 6 SPLINT KIT |
| 00026072022825 | ADULT HAND & WRIST |
| 00026072022818 | ADULT FULL LEG |
| 00026072022801 | ADULT 1/2 LEG |
| 00026072022795 | ADULT FULL ARM |
| 00026072022788 | ADULT 1/2 ARM |
| 00026072022771 | SPLINT KIT (% |
| 00026072012208 | ADULT FOOT AND ANKLE SPLINT |
| 00026072012215 | BLUE TIP TUBIN |