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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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QUANTUM TALAR IMPLANT WITH KEEL LEFT SIZE 5
IN2BONES
M50 SC275
In Commercial Distribution

  • 03701337602840 ()
M50 SC275

  • Fixed-bearing total ankle prosthesis
QUANTUM TALAR IMPLANT WITH KEEL LEFT SIZE 4
IN2BONES
M50 SC274
In Commercial Distribution

  • 03701337602833 ()
M50 SC274

  • Fixed-bearing total ankle prosthesis
QUANTUM TALAR IMPLANT WITH KEEL LEFT SIZE 3
IN2BONES
M50 SC273
In Commercial Distribution

  • 03701337602826 ()
M50 SC273

  • Fixed-bearing total ankle prosthesis
QUANTUM TALAR IMPLANT WITH KEEL LEFT SIZE 2
IN2BONES
M50 SC272
In Commercial Distribution

  • 03701337602819 ()
M50 SC272

  • Fixed-bearing total ankle prosthesis
QUANTUM TALAR IMPLANT WITH KEEL LEFT SIZE 1
IN2BONES
M50 SC271
In Commercial Distribution

  • 03701337602802 ()
M50 SC271

  • Fixed-bearing total ankle prosthesis
QUANTUM TALAR IMPLANT WITH KEEL RIGHT SIZE 6
IN2BONES
M50 SC176
In Commercial Distribution

  • 03701337602796 ()
M50 SC176

  • Fixed-bearing total ankle prosthesis
POLARIS ADJUSTABLE VALVE, 10-140 WITH ANTICHAMBER AND SIPHONX
SOPHYSA
SPVA-140-SX
In Commercial Distribution

  • 03760124131741 ()


  • Cerebrospinal fluid shunt valve
POLARIS ADJUSTABLE VALVE, 30-200 WITH ANTECHAMBER AND SIPHONX
SOPHYSA
SPVA-SX
In Commercial Distribution

  • 03760124131710 ()


  • Cerebrospinal fluid shunt valve
Rotational Knee Joint Prosthesis,with anti-luxation device, intracondylar
WALDEMAR LINK GmbH & Co. KG
15-8521/35
In Commercial Distribution

  • 04026575386451 ()
15-8521/35

  • Rotating hinged total knee prosthesis
Rotational Knee Joint Prosthesis,with anti-luxation device, intracondylar
WALDEMAR LINK GmbH & Co. KG
15-8521/33
In Commercial Distribution

  • 04026575386444 ()
15-8521/33

  • Rotating hinged total knee prosthesis
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