BTL-703

GUDID B108703POENUS0100

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system
Primary Device IDB108703POENUS0100
NIH Device Record Key5d5ab3ab-f359-4014-81e8-910ab1bca6e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBTL-703
Version Model NumberBTL-703
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
HIBCCB108703POENUS0100 [Primary]

FDA Product Code

IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-24
Device Publish Date2019-04-16

Devices Manufactured by BTL INDUSTRIES LIMITED

B108043PO30WMUS00 - LS-60002024-04-01
B108451POSCAEL2MUS00 - Scanning System for LS-60002024-04-01
B108899AP2C2MUS20 - Small applicator2023-12-18
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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