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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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Alpha-Tec Systems - 00816085022192

5% Formalin 3.875L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022192 ()
0003805

  • Faecal specimen collection kit IVD, home-use

Arthrex® - 00888867004689

RETROCUTTER, 5 MM
ARTHREX, INC.
AR-1204R-05S
In Commercial Distribution

  • 00888867004689 ()
AR-1204R-05S

  • Bone-resection orthopaedic reamer, single-use

BOSS Instruments - 00888515187689

Penfield Diss, #5
BOSS INSTRUMENTS, LTD., INC.
73-5009
In Commercial Distribution

  • 00888515187689 ()
73-5009

  • Open-surgery dissector

Knee Instruments - 07630345737748

Shim slotted -5
Medacta International SA
02.15.10.0012
In Commercial Distribution

  • 07630345737748 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

TriplePlay - 00817377021190

FM5 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40312-0001
In Commercial Distribution

  • 00817377021190 ()


  • Polysomnograph

TriplePlay - 00817377021145

FM4 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40302-0001
In Commercial Distribution

  • 00817377021145 ()


  • Polysomnograph

TriplePlay - 00817377021077

FM3 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40205-0001
In Commercial Distribution

  • 00817377021077 ()


  • Polysomnograph

TriplePlay - 00817377021060

FM2 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40204-0001
In Commercial Distribution

  • 00817377021060 ()


  • Polysomnograph

TriplePlay - 00817377020872

FM1 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-10003-0001
In Commercial Distribution

  • 00817377020872 ()


  • Polysomnograph

M.BLUE - 04041906504403

M.BLUE 5 VALVE
Aesculap AG
FX801T
In Commercial Distribution

  • 04041906504403 ()

  • Pressure rating horiz. (cmH2O) : 5.000 CWS
FX801T

  • Cerebrospinal fluid shunt valve
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