Fraxis Duo Needle H/P

GUDID 08800023200041

FRX 2.0 Needle H/P

ILOODA.CO.,LTD

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system
Primary Device ID08800023200041
NIH Device Record Key4b8eedcc-f4a4-4aea-ae6d-487df53aea38
Commercial Distribution StatusIn Commercial Distribution
Brand NameFraxis Duo Needle H/P
Version Model NumberFRX 2.0 Needle H/P
Company DUNS631129749
Company NameILOODA.CO.,LTD
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

Customer Support Contacts

Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com
Phone+821091905072
Emailcharles.jeong@ilooda.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800023200041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUHSkin Resurfacing Rf Applicator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-04-04
Device Publish Date2016-12-16

Devices Manufactured by ILOODA.CO.,LTD

08800023200942 - Secret DUO Main Unit2023-09-07
08800023200959 - Secret DUO Standard Handpiece2023-09-07
08800023201239 - Secret DUO Bigger Handpiece2023-09-07
08800023201390 - Secret DUO Laser Handpiece2023-09-07
08800023202168 - reepot Main Unit2023-09-07
08800023202175 - reepot Handpiece2023-09-07
08800023200218 - VIKINI Main Unit2023-06-19
08800023200225 - VIKINI Laser H/P2023-06-19 DET Laser H/P

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