| Primary Device ID | 00853383006745 |
| NIH Device Record Key | 49e05dc4-4e7f-47b5-bda4-825be99466fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wykle Wedges 11mm Natural Color 500 count |
| Version Model Number | 711 |
| Company DUNS | 614557155 |
| Company Name | Wykle Research, 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 | true |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |