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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator for rectal suppository
Definition Intended for use in the insertion of suppositories into the rectum
Product CodeOOW
Regulation Number 876.4730
Device Class 1


Premarket Reviews
ManufacturerDecision
CHRISTCOT MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Activation 1 1
Difficult to Open or Close 1 1
Improper Flow or Infusion 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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