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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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PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (1 ml)
3-D MATRIX INC.
651-004
Not in Commercial Distribution

  • 00860007400315 ()
651-004

  • Synthetic peptide haemostatic agent
PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 ml)
3-D MATRIX INC.
651-005
In Commercial Distribution

  • 00860007400308 ()
651-005

  • Synthetic peptide haemostatic agent
The IVX Station Reconstitution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source for use in the preparation of final compounded drugs for patient infusion administration.
Omnicell, Inc.
IVX Station Reconstitution Transfer Set
In Commercial Distribution

  • 00860007260421 ()
  • 10860007260428 ()
  • 20860007260425 ()


  • Compounding transfer set
The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
Omnicell, Inc.
IVX Station Stock Solution Transfer Set
In Commercial Distribution

  • 10860007260404 ()
  • 00860007260407 ()
  • 20860007260401 ()


  • Compounding transfer set
Oscillating Saw Packaged Assembly
Insurgical, Inc.
320-0067-001
In Commercial Distribution

  • 00860007230035 ()
3010002

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Reciprocating Saw Packaged Assembly
Insurgical, Inc.
320-0071-001
In Commercial Distribution

  • 00860007230028 ()
3010003

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Drill-Reamer Packaged Assembly
Insurgical, Inc.
320-0064-001
In Commercial Distribution

  • 00860007230004 ()
3010001

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Xpan 12mm Cannula with Obturator, Standard Length (x1)
Xpan Inc.
XP1077-01
In Commercial Distribution

  • 10860007212236 ()
  • 00860007212239 ()
  • 20860007212233 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic trocar blade, single-use
Xpan 5mm Cannula with Obturator, Standard Length (x1)
Xpan Inc.
XP1076-01
In Commercial Distribution

  • 10860007212229 ()
  • 00860007212222 ()
  • 20860007212226 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic trocar blade, single-use
Xpan 3mm Expandable Trocar with Obturator, Standard Length (x1)
Xpan Inc.
XP1075-01
In Commercial Distribution

  • 00860007212215 ()
  • 10860007212212 ()
  • 20860007212219 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic trocar blade, single-use
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