BTL Exilite handpiece

GUDID B108216APIPLF1140US1020

BTL INDUSTRIES LIMITED

Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device IDB108216APIPLF1140US1020
NIH Device Record Keyb0f0e242-f268-4d8a-b97f-2fe53b0996dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBTL Exilite handpiece
Version Model NumberBTL Exilite handpiece
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
HIBCCB108216APIPLF1140US1020 [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 handpiece]

B108216APIPLF1140US1020BTL Exilite handpiece
B108216APIPLF1140US0BTL Exilite handpiece
B108216APIPLF1140ENUS0BTL Exilite handpiece

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