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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessory, assisted reproduction, exempt
Definition This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePUB
Regulation Number 884.6120
Device Class 2


Premarket Reviews
ManufacturerDecision
COOPERSURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2019 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2 2
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 2 2
No Clinical Signs, Symptoms or Conditions 1 1

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