BTL-585

GUDID B108585POMUS00

BTL INDUSTRIES LIMITED

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator
Primary Device IDB108585POMUS00
NIH Device Record Keyfe7b67a2-7358-4ba2-ac4a-86aca268ee33
Commercial Distribution StatusIn Commercial Distribution
Brand NameBTL-585
Version Model NumberBTL-585
Company DUNS733532951
Company NameBTL INDUSTRIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB108585POMUS00 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

Devices Manufactured by BTL INDUSTRIES LIMITED

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B108899AP2C45MUS10 - Edge applicator2023-12-18
B108899APC1ENUS0140 - Large applicator2023-12-18
B108899PO11C1ENUS0140 - EMSCULPT NEO2023-12-18
B108785PO8MUS00 - BTL-785F2023-12-11
B108785PO9MUS00 - BTL-785F2023-12-11

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