BTL Exilite

GUDID B108716POIPLEENUS3010

BTL INDUSTRIES LIMITED

Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device IDB108716POIPLEENUS3010
NIH Device Record Keyaad26531-c6ab-43cf-a864-864597b8c729
Commercial Distribution StatusIn Commercial Distribution
Brand NameBTL Exilite
Version Model NumberBTL Exilite
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
HIBCCB108716POIPLEENUS3010 [Primary]

FDA Product Code

ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

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 Date2017-05-25

On-Brand Devices [BTL Exilite]

B108716POIPLEENUS3010BTL Exilite
B108716POIPLEENUS0BTL Exilite

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