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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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ORTHOMED - B803460517A0

BRUN CURETTE OVAL HOLL.HDL. 7" # 0 ANGLED
ORTHO-MED, INC.
OM 46-0517A
In Commercial Distribution

  • B803460517A0 ()
OM 46-0517A

  • Bone curette, reusable

ACTERA - M572HES03400US011

HIP STEM UNCOLLARED SZ 0 STD OFFSET
Conformis, Inc.
HES-034-00US-01
In Commercial Distribution

  • M572HES03400US011 ()
HES-034-00US

  • Coated femoral stem prosthesis, one-piece

ACTERA - M572HES03400UH011

HIP STEM UNCOLLARED SIZE 0 High Offset
Conformis, Inc.
HES-034-00UH-01
In Commercial Distribution

  • M572HES03400UH011 ()
HES-034-00UH

  • Coated femoral stem prosthesis, one-piece

ACTERA - M572HES03400CS011

HIP STEM COLLARED SZ 0, STD OFFSET
Conformis, Inc.
HES-034-00CS-01
In Commercial Distribution

  • M572HES03400CS011 ()
HES-034-00CS

  • Coated femoral stem prosthesis, one-piece

ACTERA - M572HES03400CH011

HIP STEM COLLARED SZ 0, HIGH OFFSET
Conformis, Inc.
HES-034-00CH-01
In Commercial Distribution

  • M572HES03400CH011 ()
HES-034-00CH

  • Coated femoral stem prosthesis, one-piece

ACTERA - M572HES0340000011

HIPRX STEM SIZE 0, left or right
Conformis, Inc.
HES-034-0000-01
In Commercial Distribution

  • M572HES0340000011 ()

  • patient specific neck
HES-034-0000

  • Coated femoral stem prosthesis, one-piece

iTotal® Hip Replacement System - M572HDL060F30S011

HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 STD
Conformis, Inc.
HDL060F30S01
In Commercial Distribution

  • M572HDL060F30S011 ()

  • Group F 40mm +0 STD
HDL060F30S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060F30L011

HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 LIP
Conformis, Inc.
HDL060F30L01
In Commercial Distribution

  • M572HDL060F30L011 ()

  • Group F 40mm +0 LIP
HDL060F30L

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060F30F011

HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 FC
Conformis, Inc.
HDL060F30F01
In Commercial Distribution

  • M572HDL060F30F011 ()

  • Group F 40mm +0 FC
HDL060F30F

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060F20S011

HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 STD
Conformis, Inc.
HDL060F20S01
In Commercial Distribution

  • M572HDL060F20S011 ()

  • Group F 36mm +0 STD
HDL060F20S

  • Non-constrained polyethylene acetabular liner
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