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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rigid sterilization container with software
Definition The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility until used. The rigid sterilization container with software is designed for use with high-vacuum or pulse-vacuum steam sterilization systems.
Product CodeQJT
Regulation Number 880.6855
Device Class 2


Premarket Reviews
ManufacturerDecision
ZUNO MEDICAL, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Electro-Static Discharge 1 1
Fail-Safe Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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