Primary Device ID | B108299AP11ENUS1000 |
NIH Device Record Key | 86a48cee-a5b3-4d2d-be61-1c55fc38b724 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BTL-299-1 |
Version Model Number | BTL-299-1 |
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 | B108299AP11ENUS1000 [Primary] |
IPF | Stimulator, Muscle, Powered |
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 | 2017-01-12 |
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B108451POSCAEL2MUS00 - Scanning System for LS-6000 | 2024-04-01 |
B108899AP2C2MUS20 - Small applicator | 2023-12-18 |
B108899AP2C45MUS10 - Edge applicator | 2023-12-18 |
B108899APC1ENUS0140 - Large applicator | 2023-12-18 |
B108899PO11C1ENUS0140 - EMSCULPT NEO | 2023-12-18 |
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B108785PO9MUS00 - BTL-785F | 2023-12-11 |