DioBreeze Cart FS80023

GUDID 07290016681130

Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mobile system

FORMATK SYSTEMS LTD

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Primary Device ID07290016681130
NIH Device Record Keyf778c948-28d0-481e-b22b-bafcd765f672
Commercial Distribution StatusIn Commercial Distribution
Brand NameDioBreeze Cart
Version Model NumberFS80023
Catalog NumberFS80023
Company DUNS532396673
Company NameFORMATK SYSTEMS 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS107290016681130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-05
Device Publish Date2021-06-25

Devices Manufactured by FORMATK SYSTEMS LTD

07290016681086 - Sheerwave Plus2023-09-04 Multi-modality system supporting IPL (Intense Pulsed Light) and Laser applicators for various treatments such as Hair Removal, A
07290016681079 - DioBreeze2021-07-05 DioBreeze system supporting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction an
07290016681130 - DioBreeze Cart2021-07-05Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mobile system
07290016681130 - DioBreeze Cart2021-07-05 Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mo
07290016681437 - HR-Mini2021-07-05 Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
07290016681444 - HR-Max2021-07-05 Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
07290016681017 - Forma Light2020-02-24 System supporting IPL (Intense Pulsed Light) applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions
07290016681048 - Magma Spark Pro2019-01-16 Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Ac
07290016681055 - Magma Spark Plus2019-01-16 Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Ac
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