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Brief Summary Document - HCP
Product
SAPS™ Single Action Pumping System & SAPS™ CF Continuous Flow Single Action Pumping System– IFU number 51997978-01
Rx Statement
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended use/Indications for use
The Single Action Pumping System is intended for use with urological and/or endoscopic surgical procedures requiring continuous irrigation.
Contraindications
There are currently no known CONTRAINDICATIONS associated with the use of this device.
Precautions
There are currently no known PRECAUTIONS associated with the use of this device.
Potential adverse events
Any irrigation product may cause the following adverse event.
- Hydronephrosis
Adverse events may require additional medical or surgical intervention, or a prolonged procedure.
Warnings
There are currently no known WARNINGS associated with the use of this device.