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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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iTotal® Hip Replacement System - M572HDL060B12L011

HIP-IPOLY XE-LINER-GRP B (46-49) 32MM LIP
Conformis, Inc.
HDL060B12L01
In Commercial Distribution

  • M572HDL060B12L011 ()

  • Group B 32mm +2 LIP
HDL060B12L

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060B12F011

HIP-IPOLY XE-LINER-GRP B (46-49) 32MM FC
Conformis, Inc.
HDL060B12F01
In Commercial Distribution

  • M572HDL060B12F011 ()

  • Group B 32mm +2 FC
HDL060B12F

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060B00S011

HIP-IPOLY XE-LINER-GRP B (46-49) 28MM STD
Conformis, Inc.
HDL060B00S01
In Commercial Distribution

  • M572HDL060B00S011 ()

  • Group B 28mm +0 STD
HDL060B00S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060B00L011

HIP-IPOLY XE-LINER-GRP B (46-49) 28MM LIP
Conformis, Inc.
HDL060B00L01
In Commercial Distribution

  • M572HDL060B00L011 ()

  • Group B 28mm +0 LIP
HDL060B00L

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060B00F011

HIP-IPOLY XE-LINER-GRP B (46-49) 28MM FC
Conformis, Inc.
HDL060B00F01
In Commercial Distribution

  • M572HDL060B00F011 ()

  • Group B 28mm +0 FC
HDL060B00F

  • Non-constrained polyethylene acetabular liner

MucoSoft® - M595S4930

MucoSoft® Glaze (Bottles A & B)
PARKELL, INC.
S493
Not in Commercial Distribution

  • M595S4930 ()
S493

  • Denture reliner, soft, professional

gSource - 00840314201584

Operating Scissors 5" cvd s/b
GSOURCE LLC
gS 13.4014
In Commercial Distribution

  • 00840314201584 ()
gS 13.4014

  • Bandage scissors, reusable

gSource - 00840314201553

Operating Scissors 5" str s/b
GSOURCE LLC
gS 13.4011
In Commercial Distribution

  • 00840314201553 ()
gS 13.4011

  • Bandage scissors, reusable

General Instruments - 00840180536810

TL VBR, DISTRACTOR TIP, LATERAL B
ALPHATEC SPINE, INC.
CI-11776-L-02
In Commercial Distribution

  • 00840180536810 ()


  • Bone lever/elevator, reusable

General Instruments - 00840180536797

TL VBR, DISTRACTOR TIP, BANANA B
ALPHATEC SPINE, INC.
CI-11776-B-02
In Commercial Distribution

  • 00840180536797 ()


  • Bone lever/elevator, reusable
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