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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spatula, cervical, cytological
Product CodeHHT
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
EXCELL COMPANY LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 3 3
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Device Dislodged or Dislocated 2 2
Insufficient Information 1 1
Device Fell 1 1
Material Fragmentation 1 1
Device Damaged Prior to Use 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 1 1
Syncope/Fainting 1 1
Laceration(s) 1 1
Pain 1 1
Burning Sensation 1 1
Discomfort 1 1
Reaction 1 1
Ambulation Difficulties 1 1

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