| Primary Device ID | B108785APLMUS10 |
| NIH Device Record Key | 729756b8-deec-40df-9e26-19afa7a5c331 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXION Body applicator |
| Version Model Number | BTL-785-1 |
| Company DUNS | 733532951 |
| Company Name | BTL INDUSTRIES LIMITED |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B108785APLMUS10 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-10 |
| Device Publish Date | 2023-05-02 |
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| B108699HEADRESTMEU00 - Headrest | 2024-11-14 |
| B108899PO11C1ENUS0150 - EMSCULPT NEO | 2024-10-01 |
| B108699APM2MUS00 - EXOMIND applicator | 2024-09-05 |
| B108699PO2M2MUS00 - EXOMIND | 2024-09-05 |
| B108043PO30WMUS00 - LS-6000 | 2024-04-01 |
| B108451POSCAEL2MUS00 - Scanning System for LS-6000 | 2024-04-01 |