Exilis large applicator

GUDID B108215APLAT0

BTL INDUSTRIES LIMITED

Hyperthermia system gantry Hyperthermia system gantry
Primary Device IDB108215APLAT0
NIH Device Record Keye39585c2-0934-4a6a-a738-b15124ce184a
Commercial Distribution StatusIn Commercial Distribution
Brand NameExilis large applicator
Version Model Number215/1
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
HIBCCB108215APLAT0 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-12

On-Brand Devices [Exilis large applicator]

B108215APLATENUS0215/1
B108215APLAT0215/1

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