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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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The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.
RANDOX LABORATORIES LIMITED
CK3878
In Commercial Distribution

  • 05055273201505 ()
CK3878

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent
The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1582
Not in Commercial Distribution

  • 05055273200577 ()
AY1582

  • Amylase isoenzyme IVD, reagent
The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1580
In Commercial Distribution

  • 05055273200560 ()
AY1580

  • Amylase isoenzyme IVD, reagent
An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP3877
In Commercial Distribution

  • 05055273200362 ()
AP3877

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches.
Alafair Biosciences, Inc.
VTP2201
In Commercial Distribution

  • B454VTP22011 ()

  • Length: 2 Inch
  • Width: 2 Inch
  • Total Volume: 1 Milliliter
VTP2201

  • Tendon spacer
Detachable Coil
Micro Therapeutics, Inc.
N-2-2-T10-TS
In Commercial Distribution

  • 00836462017979 ()

  • Outer Diameter: 0.9 Millimeter
  • Length: 2 Centimeter
  • Outer Diameter: 2 Millimeter
  • Softness,Super Soft,NA;Coil Diameter,0.0095,Inches;
N-2-2-T10-TS

  • Neurovascular embolization coil
Detachable Coil
Micro Therapeutics, Inc.
N-2-2-T10-F
In Commercial Distribution

  • 00836462017320 ()

  • Outer Diameter: 2 Millimeter
  • Outer Diameter: 1 Millimeter
  • Length: 2 Centimeter
  • Softness,Standard,Fiber;Coil Diameter,0.011,Inches;
N-2-2-T10-F

  • Neurovascular embolization coil
Detachable Coil
Micro Therapeutics, Inc.
N-2-2-T10
In Commercial Distribution

  • 00836462017313 ()

  • Outer Diameter: 1 Millimeter
  • Length: 2 Centimeter
  • Outer Diameter: 2 Millimeter
  • Softness,Standard,NA;Coil Diameter,0.011,Inches;
N-2-2-T10

  • Neurovascular embolization coil
Detachable Coil
Micro Therapeutics, Inc.
N-2-2-T10-SO
In Commercial Distribution

  • 00836462017061 ()

  • Outer Diameter: 2 Millimeter
  • Length: 2 Centimeter
  • Outer Diameter: 1 Millimeter
  • Softness,Soft,NA;Coil Diameter,0.010,Inches;
N-2-2-T10-SO

  • Neurovascular embolization coil
Pellets
WRIGHT MEDICAL TECHNOLOGY, INC.
84000106
In Commercial Distribution

  • 00840420123824 ()

  • Outer Diameter: 4.8 Millimeter
  • Total Volume: 2 Milliliter
  • Weight: 2 Gram
84000106

  • Bone matrix implant, synthetic, non-antimicrobial
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