| Primary Device ID | 50732224002984 |
| NIH Device Record Key | b6cebd4f-2cc7-44ef-9148-0421f8875a8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bite Wing-Ease™ Barrier Sleeves |
| Version Model Number | BWEL |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 50 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |