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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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GMK Sphere Total Knee System - 07630030826085

Tibial Insert Fixed SPHERE Congruent #1/20 mm R
Medacta International SA
02.12.0120CR
In Commercial Distribution

  • 07630030826085 ()


  • Tibial insert

GMK Sphere Total Knee System - 07630030826078

Tibial Insert Fixed SPHERE Congruent #1/20 mm L
Medacta International SA
02.12.0120CL
In Commercial Distribution

  • 07630030826078 ()


  • Tibial insert

M.U.S.T. MINI Polyaxial Screw - 07630030863837

Cannulated Polyaxial Screw 4.0 x 20 Full thread + nut
Medacta International SA
03.75.205
In Commercial Distribution

  • 07630030863837 ()


  • Spinal bone screw, non-bioabsorbable

B-P TOTAL HIP SYSTEM - 00814193024930

B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 20 MM
ENDOTEC, INC.
01-34-2032
In Commercial Distribution

  • 00814193024930 ()

  • Length: 20 Millimeter
  • Outer Diameter: 32 Millimeter
01-34-2032

  • Bipolar humeral head outer component
  • Bipolar femoral head outer component, hemiarthroplasty
  • Ceramic-on-polyethylene total hip prosthesis

B-P TOTAL HIP SYSTEM - 00814193024923

B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 20 MM
ENDOTEC, INC.
01-34-2028
Not in Commercial Distribution

  • 00814193024923 ()

  • Length: 20 Millimeter
  • Outer Diameter: 28 Millimeter
01-34-2028

  • Bipolar humeral head outer component
  • Bipolar femoral head outer component, hemiarthroplasty
  • Ceramic-on-polyethylene total hip prosthesis

SurgiMend® - 10381780113102

SurgiMend® 16 cm x 20 cm SurgiMend 3.0
TEI BIOSCIENCES INC.
606-300-008
In Commercial Distribution

  • 10381780113102 ()

  • 16 x 20 x (2.50 - 3.80) cm x cm x mm
606-300-008

  • Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

SurgiMend® - 10381780113058

SurgiMend® 20 cm x 25 cm SurgiMend 2.0
TEI BIOSCIENCES INC.
606-200-020
In Commercial Distribution

  • 10381780113058 ()

  • 20 x 25 x (1.30 - 2.50) cm x cm x mm
606-200-020

  • Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

SurgiMend® - 10381780113003

SurgiMend® 16 cm x 20 cm SurgiMend 2.0
TEI BIOSCIENCES INC.
606-200-008
In Commercial Distribution

  • 10381780113003 ()

  • 16 x 20 x (1.30 - 2.50) cm x cm x mm
606-200-008

  • Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

SurgiMend® - 10381780112914

SurgiMend® PRS (Thin) 10 cm x 20 cm
TEI BIOSCIENCES INC.
606-004-109
In Commercial Distribution

  • 10381780112914 ()

  • 10 x 20 x (0.40 - 0.75) cm x cm x mm
606-004-109

  • Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

Integra® - 10381780074649

Integra® Microlite Disposable Suction Needle 20 Gauge, Green
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1359260
In Commercial Distribution

  • 10381780074649 ()
  • 00381780074642 ()
1359260

  • Surgical/emergency suction cannula, non-illuminating, single-use
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