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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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Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(U)
In Commercial Distribution

  • 18855036012850 ()
  • 28855036012857 ()


  • Apheresis system tubing set
B-P KNEE TIBIA PLATFORM COMPONENT, W/O BIOCOAT, W/ULTRACOAT, TYPE 0, SIZE 2 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
ENDOTEC, INC.
04-32-0462
Not in Commercial Distribution

  • 00814193021519 ()

  • SIZE 2, TYPE 0
04-32-0462

  • Cruciate-retaining total knee prosthesis
Pulset™ 3CC Syringe, A-Line, Blunt Tip w/protective sheath, 25 U BH
WESTMED, INC.
3300-31
In Commercial Distribution

  • 00709078003134 ()
  • 00709078003578 ()


  • Arterial blood sampling kit
Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)
CLINICAL INNOVATIONS, LLC
PRS-0530
In Commercial Distribution

  • 30814247020346 ()
  • 40814247020343 ()


  • Abdominal retractor, hand-held
Pulset 3cc Syringe 23g x 1" (.6 x 25mm) Q-Cork 25 u Balanced Heparin
WESTMED, INC.
3303
In Commercial Distribution

  • 00709078007286 ()
  • 10709078007290 ()


  • Arterial blood sampling kit
1cc Syringe 25g x 5/8" (0.5 x 15.9mm) Mosquito 25 u Balanced Heparin
WESTMED, INC.
3105-94
Not in Commercial Distribution

  • 00709078006654 ()
  • 10709078006668 ()


  • Arterial blood sampling kit
LIQUID REPELLENT DRAPE CM 133X200 WITH ADHESIVE U SHAPE CM 6,5X50 REINFORCED - SONTARA - BLUE
OMNIA SRL
22.T1782.00
In Commercial Distribution

  • 08056646501984 ()
  • 08056646501977 ()


  • Patient surgical drape, single-use
Disposable Needle Guides for use with Mindray DE11-3(s,E,P,U) Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-031
In Commercial Distribution

  • 16971554726832 ()
  • 06971554726835 ()
10683

  • Needle guide, single-use
LIQUID REPELLENT DRAPE CM 133X200 WITH NON-ADHESIVE U SHAPE CM 6,5X50 AND LOOP - SONTARA - BLUE
OMNIA SRL
12.T1739.00
In Commercial Distribution

  • 08056646502400 ()
  • 08056646502394 ()


  • Patient surgical drape, single-use
LIQUID REPELLENT DRAPE CM 133X200 WITH ADHESIVE U SHAPE CM 6,5X50 AND LOOP - SONTARA - BLUE
OMNIA SRL
12.T1792.00
Not in Commercial Distribution

  • 08056646502127 ()
  • 08056646502110 ()


  • Patient surgical drape, single-use
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