Professional System Main Controller Unit

GUDID B271MCU0

Meditech International Inc

Red-light phototherapy unit, line-powered
Primary Device IDB271MCU0
NIH Device Record Key7091c243-4756-4686-88e5-d9b00837cedf
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfessional System Main Controller Unit
Version Model NumberMCU
Company DUNS255079485
Company NameMeditech International Inc
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB271MCU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-09

Devices Manufactured by Meditech International Inc

B271MCUI0 - MiniPort Main Controller Unit2023-10-10
B271ART1800 - ART1802023-09-26
B271CUPA0 - Arthritis Controller Unit2023-09-26
B271CU0 - CU Controller2018-07-06
B271CUP0 - CU+ Controller2018-07-06
B271DUO1800 - DUO+ 180 Treatment Head2018-07-06
B271DUO2400 - DUO+ 240 Treatment Head2018-07-06
B271LDI2000 - LD-I 200 Treatment Head2018-07-06

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