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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Acetabular Shell, Cementless, PC, 44mm
Shalby Advanced Technologies, Inc.
1703-0-0044
In Commercial Distribution

  • 00840286808446 ()
1703-0-0044

  • Acetabular shell
Acetabular Shell, Cementless, PC, 42mm
Shalby Advanced Technologies, Inc.
1703-0-0042
In Commercial Distribution

  • 00840286808439 ()
1703-0-0042

  • Acetabular shell
TABLEPAD 2" OPEN CELL XSMALL
BURLINGTON MEDICAL, LLC
TP2OPENXS
In Commercial Distribution

  • 00840186641792 ()


  • Operating table mattress, basic
Endoline PUNC and Endoline VIPER
PRINCE MEDICAL
B-4815
In Commercial Distribution

  • 03665039005630 ()
B-4815

  • Gastrointestinal needle catheter
  • Flexible endoscopic tissue manipulation forceps, single-use
The deflation needle is used to drain gastric balloons
PRINCE MEDICAL
SN4000718
In Commercial Distribution

  • 03665039001663 ()
SN4000718

  • Gastrointestinal needle catheter
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
38PP185
In Commercial Distribution

  • 08683463400208 ()

  • Outer Diameter: 2.93 Millimeter
  • Length: 120 Centimeter
38PP185

  • Cardiac defect occluder
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
38PP165
In Commercial Distribution

  • 08683463400185 ()

  • Outer Diameter: 2.73 Millimeter
  • Length: 120 Centimeter
38PP165

  • Cardiac defect occluder
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
38PP125
In Commercial Distribution

  • 08683463400161 ()

  • Outer Diameter: 2.13 Millimeter
  • Length: 120 Centimeter
38PP125

  • Cardiac defect occluder
GOWN, ISOLATION LEVEL 1, BLUE, UNIVERSAL SIZE, HOOK & LOOP NECK, FULL BACK W/TIE AT WAIST, ELASTIC SLEEVE, 5EA/PK, 20PK/CS (100EA/CS)
Asp Global, LLC
HH-2020-060-1
In Commercial Distribution

  • 00840216123014 ()


  • Isolation gown, single-use
An electronic device used to program the ASSURE system and assist in patient fitting and training
Kestra Medical Technologies, Inc.
80041-002
In Commercial Distribution

80041-002

  • Wearable defibrillation system defibrillator
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