BTL Chair Applicator

GUDID B108A299AP13ENUS1020

BTL INDUSTRIES LIMITED

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Primary Device IDB108A299AP13ENUS1020
NIH Device Record Key73ce2298-dfe4-4c8f-a025-be6d28d6dd3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBTL Chair Applicator
Version Model NumberBTL Chair Applicator
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
HIBCCB108A299AP13ENUS1020 [Primary]

FDA Product Code

KPIStimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-25

On-Brand Devices [BTL Chair Applicator]

B108A299AP13ENUS1020BTL Chair Applicator
B108A299AP13ENUS1010BTL Chair Applicator
B108899AP2M3MUS00899-AP-M-3

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