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The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
EDP 901400
In Commercial Distribution
- 03661690000243 ()
EDP 901400
- Physical therapy ultrasound system
SpO2 Module Interface Cable Included
Covidien LP
DL10076644
Not in Commercial Distribution
- 10884521582460 ()
- Patient monitoring system module, pulse oximetry
No Description
NEOCOIL, LLC
11
In Commercial Distribution
- 00856181003114 ()
- MRI system coil, radio-frequency
No Description
MANI, INC.
11
In Commercial Distribution
- 04546951500023 ()
- 14546951500020 ()
11
- Silk suture
FRESH WHOLE BLOOD
DONOR SET
Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea
Gauze Sponge 2 ea Chlorhexidine Swab 1 ea
Blood Tube- Lavender Top 4 ea Kelly Clamp 1 ea
Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea
Blood Collection Needle 1 ea Beaded Cable Tie 1 ea
Surgical Tape 1 ea Permanent Marker 1 ea
Clear IV Dressing 1 ea ASBP 572 1 ea
ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea
Blood Collection Bag 1 ea Instructions for Use 1 ea
Gloves (Pair) 1 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution
- M68980801D110 ()
80-801-D
- Blood donor set, single-pack
18 GA. Catheter 1 ea
20 GA. Catheter 1 ea
Saline Flush (5cc pre-filled syringe) 1 ea
Povidone Prep Pad 1 ea
Alcohol Prep Pad 2 ea
Needle Free Valve w/ Luer Lock 1 ea
Constricting Band 1 ea
Transparent Film Dressing 1 ea
Sterile Gauze Pad 2 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution
- M68980110110 ()
80-110
- Wound irrigation cannula
18 GA Catheter 1 ea
20 GA Catheter 1 ea
Saline Flush (5cc pre-filled syringe) 1 ea
Povidone Prep Pad 1 ea
Alcohol Prep Pad 2 ea
IV Administration Set 1 ea
Needle Free Valve with Luer Lock 1 ea
Constricting Band 1 ea
IV Catheter Dressing 1ea
Transparent Film Dressing 1 ea
Adhesive Bandage 1 ea
2"x2" Gauze Pad (2 pack) 1 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution
- M68980100110 ()
80-100
- Intraosseous infusion kit
ADVANCED LTOWB COLLECTION SET
Constricting Band (18" x 1") 1 ea
Gauze Sponge 2 ea
Safety IV Cath 16G x 1.25" 2 ea
Prevahex Transparent Dressing (4" x 4.75") 2 ea
Blood Collection Bag 1 ea
Gloves 1 pr
Chlorhexidine Swab 2 ea
Kelly Clamp 1 ea
Needle Port 2 ea
Beaded Cable Tie 1 ea
Nylon Cord (10") 1 ea
ASBP 572 1 ea
Blood Bag Label 1 ea
Valkyrie TCCC Card 1 ea
Instructions for Use 1 ea
Safeguard US Operating, LLC
11
In Commercial Distribution
- M68980820110 ()
80-820
- Blood transfusion set, non-exchange
he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient information, screen for ABO/Rh compatibility and transfuse fresh whole blood in a compact sealed package.
The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
11
In Commercial Distribution
- M68980801R110 ()
80-801-R
- Blood transfusion set, non-exchange
DICOM picture archiving system
Oehm und Rehbein GmbH
11
In Commercial Distribution
- 04250802900022 ()
L1000
- Radiology DICOM image processing application software