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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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Tibial Insert, PS, VitalitE, 3, 18mm
Shalby Advanced Technologies, Inc.
5100-0-1318
In Commercial Distribution

  • 00840286838320 ()
5100-0-1318

  • Tibial insert
Tibial Insert, PS, VitalitE, 3, 16mm
Shalby Advanced Technologies, Inc.
5100-0-1316
In Commercial Distribution

  • 00840286838313 ()
5100-0-1316

  • Tibial insert
Tibial Insert, PS, VitalitE, 3, 14mm
Shalby Advanced Technologies, Inc.
5100-0-1314
In Commercial Distribution

  • 00840286838306 ()
5100-0-1314

  • Tibial insert
Tibial Insert, PS, VitalitE, 3, 12mm
Shalby Advanced Technologies, Inc.
5100-0-1312
In Commercial Distribution

  • 00840286838290 ()
5100-0-1312

  • Tibial insert
Tibial Insert, PS, VitalitE, 3, 10mm
Shalby Advanced Technologies, Inc.
5100-0-1310
In Commercial Distribution

  • 00840286838283 ()
5100-0-1310

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, SINGLE, 13MM, LEFT & RIGHT
Conformis, Inc.
RCR010130H11
In Commercial Distribution

  • M572RCR010130H111 ()
RCR-010-130H

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, SINGLE, 13MM, LEFT & RIGHT
Conformis, Inc.
RCR010130H01
In Commercial Distribution

  • M572RCR010130H011 ()
RCR-010-130H

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, MEDIAL, 13MM, LEFT
Conformis, Inc.
RCR010130014
In Commercial Distribution

  • M572RCR0101300141 ()
RCR-010-1300

  • Tibial insert
N/A
Conformis, Inc.
RCR010130013
In Commercial Distribution

  • M572RCR0101300131 ()

  • Height: 13 Millimeter
RCR0101300

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, MEDIAL, 13MM, LEFT & RIGHT
Conformis, Inc.
RCR010130004
In Commercial Distribution

  • M572RCR0101300041 ()
RCR-010-1300

  • Tibial insert
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