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The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
PROCEPT BIOROBOTICS CORPORATION
351101
In Commercial Distribution
- B6143511011 ()
- B6143511018 ()
- B6143511012 ()
351101
- Patient surgical drape, single-use
No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution
- B598GMMHT0001 ()
- B598GMMHT0002 ()
- B598GMTRK0001 ()
- Penile vacuum device
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution
- B595L2050R0 ()
- B595L2050R1 ()
- B595L2050R2 ()
L2050R
- Pulse oximeter probe, reusable
- Pulse Co-oximeter probe, reusable
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-S
In Commercial Distribution
- B090E20130S1 ()
- B090E20130S0 ()
- B090E20130S2 ()
- Catheter Length: 130 Centimeter
- Catheter Gauge: 2 French
E20-130-S
- Vascular microcatheter
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-B
In Commercial Distribution
- B090E20130B1 ()
- B090E20130B0 ()
- B090E20130B2 ()
- Catheter Length: 130 Centimeter
- Catheter Gauge: 2 French
E20-130-B
- Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-S
In Commercial Distribution
- B0902P0130S1 ()
- B0902P0130S0 ()
- B0902P0130S2 ()
- Catheter Length: 130 Centimeter
- Catheter Gauge: 2 French
2P0-130-S
- Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-B
In Commercial Distribution
- B0902P0130B1 ()
- B0902P0130B0 ()
- B0902P0130B2 ()
- Catheter Length: 130 Centimeter
- Catheter Gauge: 2 French
2P0-130-B
- Vascular microcatheter
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution
- M729700580I1 ()
- M729700580I0 ()
- M729700580I3 ()
- Catheter Gauge: 7 French
- Catheter Gauge: 6 French
- Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution
- M729700500DX1 ()
- M729700500DX0 ()
- M729700500DX3 ()
- Catheter Gauge: 5 French
- Femoral artery closure plug/patch, collagen
1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution
- B353UB15501 ()
- B353UB15502 ()
- B353UB15503 ()
- Wearable multiple physiological parameter recorder, reusable