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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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Ready-to-Use components for high sensitivity 2-step detection system designed for detection of specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.
BIO SB, INC.
Ready-to-use, 15 ml each
In Commercial Distribution

  • B502BSB0001LH0 ()
BSB 0001LH

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual test strips in pouches; 50 tests per box. Market--physician office
R MEDICAL SUPPLY INC
C1001S-A
In Commercial Distribution

  • B497542100C1001S1 ()
  • B497542100C1001S11 ()


  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)
The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
INTEGRA LIFESCIENCES CORPORATION
221685
Not in Commercial Distribution

  • M2482216851 ()
  • 10381780065876 ()

  • 8.5 mm dia x 31 mm L
221685

  • Elbow radius prosthesis
The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
INTEGRA LIFESCIENCES CORPORATION
221680
Not in Commercial Distribution

  • M2482216801 ()
  • 10381780065869 ()

  • 8.0 mm dia x 31 mm L
221680

  • Elbow radius prosthesis
The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
INTEGRA LIFESCIENCES CORPORATION
221670
Not in Commercial Distribution

  • M2482216701 ()
  • 10381780065852 ()

  • 7.0 mm dia x 31 mm L
221670

  • Elbow radius prosthesis
The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
INTEGRA LIFESCIENCES CORPORATION
221660
Not in Commercial Distribution

  • M2482216601 ()
  • 10381780065845 ()

  • 6.0 mm dia x 31 mm L
221660

  • Elbow radius prosthesis
The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
Ascension Orthopedics, Inc.
221675
In Commercial Distribution

  • M2482216751 ()
  • 10381780065821 ()

  • 7.5 mm dia x 31 mm L
221675

  • Elbow radius prosthesis
The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
Ascension Orthopedics, Inc.
221665
In Commercial Distribution

  • M2482216651 ()
  • 10381780065814 ()

  • 6.5 mm dia x 31 mm L
221665

  • Elbow radius prosthesis
The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
Ascension Orthopedics, Inc.
221424
In Commercial Distribution

  • M2482214241 ()
  • 10381780065807 ()

  • 24 mm dia x 9.22 mm depth
221424

  • Elbow radius prosthesis
The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
Ascension Orthopedics, Inc.
221421
In Commercial Distribution

  • M2482214211 ()
  • 10381780065791 ()

  • 21 mm dia x 8.73 mm depth
221421

  • Elbow radius prosthesis
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