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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
ARNOLD TUBER INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
HU-FRIEDY MFG. CO. LLC
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KI WORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEIBACH TECH LTDA
  SUBSTANTIALLY EQUIVALENT 1
MILTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 1 1
2017 3 3
2018 1 1
2021 1 1
2023 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
Break 1 1
Detachment Of Device Component 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Connection Problem 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 5 5
No Information 1 1
Unspecified Tissue Injury 1 1
Fever 1 1
Unspecified Infection 1 1
Sepsis 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Milestone Scientific, Inc. III Jul-01-2015
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