| Primary Device ID | 00840117349247 |
| NIH Device Record Key | f9e1f5e7-645d-45e4-9c14-1f5061b6b583 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ActiSplint with Sensi-Wrap |
| Version Model Number | 3533 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117349247 [Primary] |
| GS1 | 00840117349254 [Package] Package: Case [50 Units] In Commercial Distribution |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2026-03-18 |
| Device Publish Date | 2021-09-01 |
| 00616784353319 | ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage |
| 00840117349247 | ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage |