| Primary Device ID | D867ELISM0 |
| NIH Device Record Key | 5369acbd-9f86-4bf2-a670-73059841526d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elbow Immobilizer Pedo |
| Version Model Number | ELISM |
| Catalog Number | ELISM |
| Company DUNS | 804495695 |
| Company Name | Xemax Surgical Products 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 | false |
| Lot Batch | false |
| 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 |
|---|---|
| HIBCC | D867ELISM0 [Primary] |
| IQI | Orthosis, Limb Brace |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-20 |
| Device Publish Date | 2023-06-12 |
| D867ELILG0 - Elbow Immobilizer | 2023-06-20 Elbow immobilizer with Velcro straps. |
| D867ELISM0 - Elbow Immobilizer Pedo | 2023-06-20Elbow immobilizer with Velcro straps. Pedo size. |
| D867ELISM0 - Elbow Immobilizer Pedo | 2023-06-20 Elbow immobilizer with Velcro straps. Pedo size. |
| D867OSSF0 - Osseo II Bone Trap | 2023-06-20 Osseous Bone Trap |
| D867RLH0 - Right Light | 2023-06-20 Battery powered head lamp. |
| D867CL360051 - Cusp-Lok | 2022-09-19 Orthodontic bracket with chain |
| D867CL360101 - Cusp-Lok | 2022-09-19 Orthodontic bracket with chain |
| D867CLCMLP051 - Cusp-Lok | 2022-09-19 Orthodontic bracket with chain |
| D867CLCMLP101 - Cusp-Lok | 2022-09-19 Orthodontic bracket with chain |