| Primary Device ID | B15170408A0 |
| NIH Device Record Key | 49e2a70c-2a91-48ae-8941-839c3bcaf98d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | St. Louis Band |
| Version Model Number | 704.08A |
| Catalog Number | 704.08A |
| Company DUNS | 604405373 |
| Company Name | ORTHOMERICA PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 18004466770 |
| custserv@orthomerica.com | |
| Phone | 18004466770 |
| custserv@orthomerica.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B15170408A0 [Primary] |
| MVA | Orthosis, Cranial |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-22 |
| B15176308PA0 | The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr |
| B15176308A0 | The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr |
| B15170908PA0 | The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr |
| B15170908A0 | The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr |
| B15170408PA0 | The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr |
| B15170408A0 | The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr |