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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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b-ONE™ Primary Acetabular System - 00843575102256

Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size G
B-ONE ORTHO, CORP.
881200281G
In Commercial Distribution

  • 00843575102256 ()
881200281G

  • Non-constrained polyethylene acetabular liner

HI-TORQUE COMMAND - 08717648212123

Hi-Torque Command 18 ST Guide Wire .018" 10 cm / 4 g, 210 cm
ABBOTT VASCULAR INC.
1013730
In Commercial Distribution

  • 08717648212123 ()
  • 28717648212127 ()
1013730

  • Peripheral vascular guidewire, manual

HI-TORQUE COMMAND - 08717648211980

Hi-Torque Command 18 LT Guide Wire .018" 25 cm / 4 g, 300 cm
ABBOTT VASCULAR INC.
1013753
In Commercial Distribution

  • 28717648211984 ()
  • 08717648211980 ()
1013753

  • Peripheral vascular guidewire, manual

iTotal Identity CR - M572RCR020000G141

ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, G, LEFT & RIGHT
Conformis, Inc.
RCR020000G14
In Commercial Distribution

  • M572RCR020000G141 ()
RCR-020-000G

  • Tibial insert

iTotal® CR iPoly® XE Insert Kit - M572RCR020000G131

ITOTAL CR IPOLY XE LATERAL G INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000G13
In Commercial Distribution

  • M572RCR020000G131 ()

  • Patient Specific
RCR020000G

  • Tibial insert

Nutriline Twinflo - 08498840000137

NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER AND MICROFLASH INTRODUCER
Vygon Corporation
1252.232M
In Commercial Distribution

  • 38498840000138 ()
  • 08498840000137 ()

  • Outer Diameter: 24 Millimeter
1252.232M

  • Peripherally-inserted central venous catheter

Premicath - 08498840009536

PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND NEOCATH SPLIT
Vygon Corporation
1261.205G
In Commercial Distribution

  • 38498840009537 ()
  • 08498840009536 ()

  • Outer Diameter: 24 Millimeter
1261.205G

  • Peripherally-inserted central venous catheter

Premicath - 08498840008508

PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND MICROFLASH INTRODUCER
Vygon Corporation
1261.208G
In Commercial Distribution

  • 38498840008509 ()
  • 08498840008508 ()

  • Outer Diameter: 24 Millimeter
1261.208G

  • Peripherally-inserted central venous catheter

Premicath - 08498840008485

PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE
Vygon Corporation
1261.203G
In Commercial Distribution

  • 38498840008486 ()
  • 08498840008485 ()

  • Outer Diameter: 24 Millimeter
1261.203G

  • Peripherally-inserted central venous catheter

HI-TORQUE COMMAND - 08717648212130

Hi-Torque Command 18 ST Guide Wire .018" 10 cm / 4 g, 300 cm
ABBOTT VASCULAR INC.
1013731
In Commercial Distribution

  • 28717648212134 ()
  • 08717648212130 ()
1013731

  • Peripheral vascular guidewire, manual
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