Device Reproductive Toxicity Problem Evaluation Result

The device or component affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3) (Food and Drug Administration)

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Device Reproductive Toxicity Evaluation Method

Evaluating a device for chemicals or other agents that may have caused problems with the reproductive system. This includes evaluating a device…

Device Reprocessed Code

A coded value specifying whether a device is reconditioned.

Device Repaired and Returned Evaluation Conclusion

The device was repaired and returned to the user (reporter) following a reported device problem.

Device Reactivity Testing Evaluation Method

Testing the device for problems related to how the materials react to other factors (e.g. over-react or under-react).

Device Reactivity Problem Evaluation Result

A device problem related to how the materials react inappropriately (e.g. over-react or under-react).

Device Radiologic Evaluation Method

Evaluating the safety provisions in a device used for medical imaging, i.e., if the device can cause injury to individuals during imaging…