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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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DYNASTY® A-CLASS® 15 DG POLY LINER 36MM GROUP E
Microport Orthopedics Inc.
DLXPLE36
In Commercial Distribution

  • DLXPLE36 ()
  • M684DLXPLE361 ()

  • Lumen/Inner Diameter: 36 Millimeter
DLXPLE36

  • Non-constrained polyethylene acetabular liner
ITOTAL CR–IPOLY XE–LATERAL E INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000E03
In Commercial Distribution

  • M572RCR020000E031 ()

  • Thickness 10mm
RCR-020-000E

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL E INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000E13
In Commercial Distribution

  • M572RCR020000E131 ()

  • Patient Specific
RCR020000E

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, LATERAL, E, LEFT & RIGHT
Conformis, Inc.
RCR010000E04
In Commercial Distribution

  • M572RCR010000E041 ()
RCR-010-000E

  • Tibial insert
ApeX-LNK Acetabular Insert, UHMWPE 10 degree Hood, E Insert/28mm ID
Omni Life Science, Inc.
H5-54828
In Commercial Distribution

  • 00841690120025 ()
H5-54828

  • Non-constrained polyethylene acetabular liner
ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, E Insert/40mm ID
Omni Life Science, Inc.
H5-44840
In Commercial Distribution

  • 00841690119906 ()
H5-44840

  • Non-constrained polyethylene acetabular liner
ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, E Insert/36mm ID
Omni Life Science, Inc.
H5-44836
In Commercial Distribution

  • 00841690119890 ()
H5-44836

  • Non-constrained polyethylene acetabular liner
IB3D TB (E) 13 x 06° x 28 x 10 mm
MEDICREA INTERNATIONAL
B242E13062810
Not in Commercial Distribution

  • 03613720273226 ()


  • Metallic spinal interbody fusion cage
IB3D TB (E) 12 x 06° x 28 x 10 mm
MEDICREA INTERNATIONAL
B242E12062810
Not in Commercial Distribution

  • 03613720273202 ()


  • Metallic spinal interbody fusion cage
IB3D TB (E) 11 x 06° x 28 x 10 mm
MEDICREA INTERNATIONAL
B242E11062810
Not in Commercial Distribution

  • 03613720273189 ()


  • Metallic spinal interbody fusion cage
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