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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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SmartFrame - 00850359007072

SMARTFrame XG TwistPoint Kit w/ HC - E
Clearpoint Neuro, Inc.
CP-NGS-11-HC-TP32-E
Not in Commercial Distribution

  • 00850359007072 ()
CP-NGS-11-HC-TP32-E

  • Neurological stereotactic surgery system

iTotal® Hip Replacement System - M572HDL060E34S011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM LAT STD
Conformis, Inc.
HDL060E34S01
In Commercial Distribution

  • M572HDL060E34S011 ()

  • Group E 40mm LAT STD
HDL060E34S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E32S011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM STD (PLN)
Conformis, Inc.
HDL060E32S01
In Commercial Distribution

  • M572HDL060E32S011 ()

  • Group E 40mm STD
HDL060E32S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E30S011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 STD
Conformis, Inc.
HDL060E30S01
In Commercial Distribution

  • M572HDL060E30S011 ()

  • Group E 40mm +0 STD
HDL060E30S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E30L011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 LIP
Conformis, Inc.
HDL060E30L01
In Commercial Distribution

  • M572HDL060E30L011 ()

  • Group E 40mm +0 LIP
HDL060E30L

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E30F011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 FC
Conformis, Inc.
HDL060E30F01
In Commercial Distribution

  • M572HDL060E30F011 ()

  • Group E 40mm +0 FC
HDL060E30F

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E24S011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM LAT STD
Conformis, Inc.
HDL060E24S01
In Commercial Distribution

  • M572HDL060E24S011 ()

  • Group E 36mm LAT STD
HDL060E24S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E22S011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM STD (PLN)
Conformis, Inc.
HDL060E22S01
In Commercial Distribution

  • M572HDL060E22S011 ()

  • Group E 36mm STD
HDL060E22S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E20S011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +0 STD
Conformis, Inc.
HDL060E20S01
In Commercial Distribution

  • M572HDL060E20S011 ()

  • Group E 36mm +0 STD
HDL060E20S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E20L011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +0 LIP
Conformis, Inc.
HDL060E20L01
In Commercial Distribution

  • M572HDL060E20L011 ()

  • Group E 36mm +0 LIP
HDL060E20L

  • Non-constrained polyethylene acetabular liner
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