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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator (laryngo-tracheal), topical anesthesia
Regulation Description Laryngotracheal topical anesthesia applicator.
Product CodeCCT
Regulation Number 868.5170
Device Class 2


Premarket Reviews
ManufacturerDecision
DUALAMS, INC., DBA AIRKOR
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 3 3
2023 2 2
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Disconnection 1 1
Material Fragmentation 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Connection Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 3 3
Airway Obstruction 1 1
Device Embedded In Tissue or Plaque 1 1

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