EMFEMME V tip

GUDID B108785TIPVMUS00

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system
Primary Device IDB108785TIPVMUS00
NIH Device Record Keyc61b7dbe-5038-41f7-a64f-3b37b06a02ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMFEMME V tip
Version Model NumberEMFEMME V tip
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
HIBCCB108785TIPVMUS00 [Primary]

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-14
Device Publish Date2022-03-04

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