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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vapocoolant device
Product CodeMLY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
623 MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CRYOSCIENCE NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEBAUER COMPANY
  SUBSTANTIALLY EQUIVALENT 1
NUANCE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VAPOCOOLSHOT, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 2 2
Output Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Full thickness (Third Degree) Burn 2 2
Cryogenic Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1

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