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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, cartridge
Product CodeEJI
Regulation Number 872.6770
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED TECHNOLOGY AND CAPITAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Device Operates Differently Than Expected 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Unspecified Tissue Injury 1 1
Fever 1 1
Unspecified Infection 1 1
Sepsis 1 1

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