| Primary Device ID | 10859911004938 |
| NIH Device Record Key | 025209c6-17a5-4c2c-b3a1-2fdc60e07f9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Preemie Hand Splint |
| Version Model Number | 1150 |
| Catalog Number | 1150 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 5 |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859911004931 [Primary] |
| GS1 | 10859911004938 [Unit of Use] |
| ILH | SPLINT, HAND, AND COMPONENTS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
| 10859911004938 | Preemie Hand Splint - 5ct |
| 00714646000538 | Sample, Preemie Hand Splint |