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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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PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-104
Not in Commercial Distribution

  • 10381780113652 ()

  • 4 x 4 x (0.20 - 1.04) cm x cm x mm
6495-9-104

  • Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
607-005-220
Not in Commercial Distribution

  • 10381780113416 ()

  • 2 x 2 x (0.20 - 1.04) cm x cm x mm
607-005-220

  • Animal-derived wound matrix dressing
The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a new warranty replacement unit.
Braebon Medical Corporation
MBJR-WN
In Commercial Distribution

  • B140MBJRWN0 ()
MBJR-WN

  • Polysomnograph
The measurer is used to measure the 250mm K-wire in place and decide the compression screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire.
NEWDEAL
119511ND
Not in Commercial Distribution

  • M248119511ND1 ()
  • 10381780044796 ()


  • Surgical depth gauge, reusable
The measurer is used to measure the 200/250mm K-wire in place and decide the screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire.
NEWDEAL
119150ND
In Commercial Distribution

  • M248119150ND1 ()
  • 10381780044765 ()


  • Surgical depth gauge, reusable
Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0007151
In Commercial Distribution

  • 10888234000723 ()
0007151

  • Anti-H red blood cell grouping IVD, lectin
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-38150A
In Commercial Distribution

  • 16976055232912 ()
  • 06976055232915 ()
  • 26976055232919 ()
SF.UA11.B24

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-25080A
In Commercial Distribution

  • 16976055232745 ()
  • 06976055232748 ()
  • 26976055232742 ()
SF.UA11.B07

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-25080S
In Commercial Distribution

  • 16976055232721 ()
  • 06976055232724 ()
  • 26976055232728 ()
SF.UA11.B05

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-18080A
In Commercial Distribution

  • 16976055232707 ()
  • 06976055232700 ()
  • 26976055232704 ()
SF.UA11.B03

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-18080S
In Commercial Distribution

  • 16976055232684 ()
  • 06976055232687 ()
  • 26976055232681 ()
SF.UA11.B01

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-38080A
In Commercial Distribution

  • 16976055232905 ()
  • 06976055232908 ()
  • 26976055232902 ()
SF.UA11.B23

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-38150S
In Commercial Distribution

  • 16976055232899 ()
  • 06976055232892 ()
  • 26976055232896 ()
SF.UA11.B22

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-38080S
In Commercial Distribution

  • 16976055232882 ()
  • 06976055232885 ()
  • 26976055232889 ()
SF.UA11.B21

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35150A
In Commercial Distribution

  • 16976055232875 ()
  • 06976055232878 ()
  • 26976055232872 ()
SF.UA11.B20

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35080A
In Commercial Distribution

  • 16976055232868 ()
  • 06976055232861 ()
  • 26976055232865 ()
SF.UA11.B19

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35150S
In Commercial Distribution

  • 16976055232851 ()
  • 06976055232854 ()
  • 26976055232858 ()
SF.UA11.B18

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35080S
In Commercial Distribution

  • 16976055232844 ()
  • 06976055232847 ()
  • 26976055232841 ()
SF.UA11.B17

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-32150A
In Commercial Distribution

  • 16976055232837 ()
  • 06976055232830 ()
  • 26976055232834 ()
SF.UA11.B16

  • Gastro-urological guidewire, single-use
The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-32080A
In Commercial Distribution

  • 16976055232820 ()
  • 06976055232823 ()
  • 26976055232827 ()
SF.UA11.B15

  • Gastro-urological guidewire, single-use
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