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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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Optimotion Blue CR HCCR Total Knee System - B6961014P0111010

CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 11mm, Left
OPTIMOTION IMPLANTS LLC
1014-P-0111-01
In Commercial Distribution

  • B6961014P0111010 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P0109020

CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 9mm, Right
OPTIMOTION IMPLANTS LLC
1014-P-0109-02
In Commercial Distribution

  • B6961014P0109020 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P0109010

CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 9mm, Left
OPTIMOTION IMPLANTS LLC
1014-P-0109-01
In Commercial Distribution

  • B6961014P0109010 ()


  • Cruciate-retaining total knee prosthesis

iScreen™ - 00817405023943

4 Panel E&I Oral Click Cube AMP50, COC20, MET50, OPI40
Instant Technologies, Inc.
ABTOFCUBE0401A
In Commercial Distribution

  • 30817405023944 ()
  • 00817405023943 ()
  • 10817405023940 ()
ABTOFCUBE0401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405023516

5 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10
Instant Technologies, Inc.
ABTOFCUBE0501A
In Commercial Distribution

  • 30817405023517 ()
  • 00817405023516 ()
  • 10817405023513 ()
ABTOFCUBE0501A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

INHANCE - 10603295546818

INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø40+0mm
DEPUY (IRELAND)
5500-40-000
In Commercial Distribution

  • 10603295546818 ()
550040000

  • Total reverse shoulder prosthesis

INHANCE - 10603295546795

INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø36+4mm
DEPUY (IRELAND)
5500-36-004
In Commercial Distribution

  • 10603295546795 ()
550036004

  • Total reverse shoulder prosthesis

INHANCE - 10603295546771

INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø36+0mm
DEPUY (IRELAND)
5500-36-000
In Commercial Distribution

  • 10603295546771 ()
550036000

  • Total reverse shoulder prosthesis

INHANCE - 10603295546757

INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø32+4mm
DEPUY (IRELAND)
5500-32-004
In Commercial Distribution

  • 10603295546757 ()
550032004

  • Total reverse shoulder prosthesis

INHANCE - 10603295546733

INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø32+0mm
DEPUY (IRELAND)
5500-32-000
In Commercial Distribution

  • 10603295546733 ()
550032000

  • Total reverse shoulder prosthesis
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