Northeast Scientific

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.