| Primary Device ID | B108744POCTENUS0 |
| NIH Device Record Key | 700f463e-c3eb-48f8-ab93-9fe3f77bb076 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BTL Cellutone |
| Version Model Number | BTL Cellutone |
| Company DUNS | 733532951 |
| Company Name | BTL INDUSTRIES LIMITED |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |