| Primary Device ID | 14053613291207 |
| NIH Device Record Key | 1c5638b1-e514-4896-8feb-3e05c65a6839 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wedge 3 |
| Version Model Number | TM12913 |
| Catalog Number | TM12913 |
| Company DUNS | 317409001 |
| Company Name | Gebr. Brasseler GmbH & Co. KG |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |