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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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Wizard CaP - 00868201000133

Calcium Bone Void Filler (3 cc)
Vivorte, Inc
3 cc
Not in Commercial Distribution

  • 00868201000133 ()


  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000126

Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
Not in Commercial Distribution

  • 00868201000126 ()
131133-10

  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000119

Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000119 ()
131133-05

  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000102

Calcium compound bone void filler (3cc)
Vivorte, Inc
3 cc
Not in Commercial Distribution

  • 00868201000102 ()
131133-03

  • Bone matrix implant, synthetic, non-antimicrobial

Fortera - 00868201000164

Calcium compound bone void filler (3 cc)
Vivorte, Inc
3 cc
In Commercial Distribution

  • 00868201000164 ()
131133-03-S

  • Bone matrix implant, synthetic, non-antimicrobial

Wizard CaP - 00868201000157

Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
Not in Commercial Distribution

  • 00868201000157 ()


  • Bone matrix implant, synthetic, non-antimicrobial

Wizard CaP - 00868201000140

Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000140 ()


  • Bone matrix implant, synthetic, non-antimicrobial

DOPPLER MODEL 812 IN 901 C/C - 00816787020427

No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-901 CC
In Commercial Distribution

  • 00816787020427 ()


  • Laser Doppler blood flowmeter

DOPPLER MODEL 812 IN 800 C/C - 00816787020410

No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-800 CC
In Commercial Distribution

  • 00816787020410 ()


  • Laser Doppler blood flowmeter

Trabexus® - W4146EB0010T0475

Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
10 cc
In Commercial Distribution

  • W4146EB0010T0475 ()
130703-10

  • Cadaveric-donor/synthetic mineral bone graft
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