| Primary Device ID | B108215APSAPWRE1000 |
| NIH Device Record Key | dd2d00c4-a89b-4d02-b8b9-c69b22efb0fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XP 2 applicator |
| Version Model Number | 215-7 |
| 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 | B108215APSAPWRE1000 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-04-20 |
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| B108899AP2C2MUS20 - Small applicator | 2023-12-18 |
| B108899AP2C45MUS10 - Edge applicator | 2023-12-18 |
| B108899APC1ENUS0140 - Large applicator | 2023-12-18 |
| B108899PO11C1ENUS0140 - EMSCULPT NEO | 2023-12-18 |
| B108785PO8MUS00 - BTL-785F | 2023-12-11 |
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