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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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JOURNEY - 03596010627063

JOURNEY UNI 2 IN 1 FEMORAL BLOCK LEFT MEDIAL SIZE 5
Smith & Nephew, Inc.
74013455
In Commercial Distribution

  • 03596010627063 ()
74013455

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Safe & Soft tampons - 00834533001322

Safe & soft tampons, Super absorbency, 500 bulk tampons in a case
AL-BAD MASSUOT YITZHAK LTD
BKASBK500
In Commercial Distribution

  • 00834533001322 ()
  • 07290016625028 ()


  • Menstrual tampon, unscented

Isolation Transformer 100-120V - 07640121880902

Isolates the SDM from mains for use in home use environments.
SenTec AG
RFT100VA-V1
In Commercial Distribution

  • 07640121880902 ()


  • Pulse Co-oximeter probe, reusable
  • Transcutaneous blood gas monitor sensor
  • Transcutaneous blood gas monitoring system

OpsisDx - B550ENT0020

Additive used in preparing OpsisDx urine fixative and OpsisDx standard media
ENTOPSIS, LLC
Signal Enhancer
Not in Commercial Distribution

  • B550ENT0020 ()
ENT002

  • Multiple-type clinical chemistry analyte profile IVD, reagent

VisuCal-F Frozen Calibrator Plasma - 10629009041257

Intended for use in the calibration of coagulation and fibrinolysis assays.
Affinity Biologicals Inc
FRSP0125
In Commercial Distribution

  • 10629009041257 ()
  • 10629009040014 ()
  • 16290090041255 ()


  • Multiple coagulation factor IVD, calibrator

Visu-Cal F Frozen Calibrator Plasma - 10629009041059

Intended for use in the calibration of coagulation and fibrinolysis assays.
Affinity Biologicals Inc
FRSP0105
In Commercial Distribution

  • 10629009041059 ()
  • 10629009040014 ()
  • 16290090041057 ()


  • Multiple coagulation factor IVD, calibrator

Megadyne - 10614559105771

Bipolar Forcep Reusable Semkin 0.5 mm tip 5 in (12.7 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
4050J
Not in Commercial Distribution

  • 30614559105775 ()
  • 10614559105771 ()
  • 50614559105779 ()


  • Electrosurgical system generator

Megadyne - 10614559105726

Bipolar Forcep Reusable Adson 1.0 mm tip 4 in (10.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
4040J
Not in Commercial Distribution

  • 50614559105724 ()
  • 30614559105720 ()
  • 10614559105726 ()


  • Electrosurgical system generator

Megadyne - 10614559105719

Bipolar Forcep Reusable Cushing 1.5 mm tip 6 in (15.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
4030J
Not in Commercial Distribution

  • 50614559105717 ()
  • 30614559105713 ()
  • 10614559105719 ()


  • Electrosurgical system generator

Megadyne - 10614559105702

Bipolar Forcep Reusable Jeweler 0.4 mm tip 4 in (10.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
4020J
Not in Commercial Distribution

  • 50614559105700 ()
  • 30614559105706 ()
  • 10614559105702 ()


  • Electrosurgical system generator
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