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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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Pericardiocentesis Kit
BOSTON SCIENTIFIC CORPORATION
M00443150
In Commercial Distribution

  • 08714729333258 ()
  • 08714729744887 ()

  • 2.8 mm Diameter
  • 50 cm Effective Length
  • 8.3 F Diameter


  • Pericardiocentesis needle, single-use
Pericardiocentesis Kit
BOSTON SCIENTIFIC CORPORATION
M00443050
In Commercial Distribution

  • 08714729333234 ()
  • 08714729744856 ()

  • 2.8 mm Diameter
  • 8.3 F Diameter
  • 41 cm Effective Length


  • Pericardiocentesis needle, single-use
Pericardial Drainage Collection Bag
BOSTON SCIENTIFIC CORPORATION
M0044000
In Commercial Distribution

  • 08714729268086 ()
  • 08714729268079 ()

  • 1000 mL Volume


  • Pericardiocentesis needle, single-use
No Description
EPIEP, INC.
0399-13950
In Commercial Distribution

  • B3000399139500 ()


  • Pericardiocentesis needle, single-use
SUCTION 12006 ASPIRATING NEEDLE 16GA 20P
MEDTRONIC, INC.
12006
In Commercial Distribution

  • 20613994794578 ()
  • 00613994794574 ()

  • Needle Gauge: 16.0 Gauge


  • Pericardiocentesis needle, single-use
No Description
MANI, INC.
10
In Commercial Distribution

  • 04546951500016 ()
  • 14546951500013 ()
10

  • Nylon suture, non-bioabsorbable, monofilament
NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial's contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.
DRAGON HEART MEDICAL, INC.
R001
Not in Commercial Distribution

  • B346R0011 ()
  • B346R00129 ()
10

  • Medical air terminal unit
Open width8±1mm the max OD of insertion part 2.6mm working length 2350mm coated
Micro-Tech (Nanjing) Co., Ltd.
ROCC-C-26-235-C
Not in Commercial Distribution

  • 26932503530228 ()
  • 16932503530221 ()
  • 06932503530224 ()
ROCC-C-26-235-C

  • Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Ovesco Endoscopy AG
10
Not in Commercial Distribution

  • 04260206310839 ()
  • 04260206310846 ()

  • mounting depht of the cap: 5 mm
  • for endoscopes with diameter 5.5 - 6 mm
  • Length: 20.6 Millimeter
  • Outer Diameter: 10.1 Millimeter
400.31.03

  • Endoscopic gastrointestinal stenosis dilator
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