EXOMIND applicator

GUDID B108699APM2MUS00

BTL INDUSTRIES LIMITED

Magnetic neural stimulation system
Primary Device IDB108699APM2MUS00
NIH Device Record Key21fb8530-1b4f-47bf-aeaa-4c7c6a57cad9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXOMIND applicator
Version Model NumberBTL-699-AP-M-2
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
HIBCCB108699APM2MUS00 [Primary]

FDA Product Code

OBPTranscranial Magnetic Stimulator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-05
Device Publish Date2024-08-28

Devices Manufactured by BTL INDUSTRIES LIMITED

B108699BELTMEU00 - Belt2024-11-14
B108699HEADRESTMEU00 - Headrest2024-11-14
B108899PO11C1ENUS0150 - EMSCULPT NEO2024-10-01
B108699APM2MUS00 - EXOMIND applicator2024-09-05
B108699APM2MUS00 - EXOMIND applicator2024-09-05
B108699PO2M2MUS00 - EXOMIND2024-09-05
B108043PO30WMUS00 - LS-60002024-04-01
B108451POSCAEL2MUS00 - Scanning System for LS-60002024-04-01
B108899AP2C2MUS20 - Small applicator2023-12-18

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