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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SOFT CALF SLEEVE, Medium 2ea, [One polybag]
DAESUNG MAREF CO.,LTD.
DS222
In Commercial Distribution

  • 18809315675717 ()
  • 08809315675710 ()
  • 28809315675714 ()
  • 38809315675711 ()


  • Multi-chamber venous compression system garment, reusable
SOFT CALF SLEEVE Small 2ea, [One polybag]
DAESUNG MAREF CO.,LTD.
DS221
In Commercial Distribution

  • 18809315675700 ()
  • 08809315675703 ()
  • 28809315675707 ()
  • 38809315675704 ()


  • Multi-chamber venous compression system garment, reusable
SOFT BOOT SLEEVE Medium 2ea, [One polybag]
DAESUNG MAREF CO.,LTD.
DS241
In Commercial Distribution

  • 18809315675694 ()
  • 08809315675697 ()
  • 28809315675691 ()
  • 38809315675698 ()


  • Multi-chamber venous compression system garment, reusable
Coolject Standard Nozzle Accessory, One per Box
Vapocoolshot, Inc
VM01100-00
In Commercial Distribution

  • 00860006961558 ()


  • Cold/cool therapy spray
PACK TK1S04 ONE SOURCE SEQ1000 125 4M
MEDTRONIC, INC.
TK1S04
Not in Commercial Distribution

  • 00673978524856 ()


  • Autotransfusion system blood component processing set
One time use sterile emergency airway kit
H&H MEDICAL CORPORATION
Version 1
Not in Commercial Distribution

  • 00857048006019 ()

  • Height: 1.75 Inch
  • Width: 4.0 Inch
  • Length: 9.25 Inch
HHCCP01

  • Cricothyrotomy kit, single-use
UltraVision ONE Detection System HRP Polymer (Ready-To-Use)
RICHARD-ALLAN SCIENTIFIC COMPANY
TL-125-HLJ
In Commercial Distribution

  • 00673693405010 ()

  • Total Volume: 125 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
UltraVision ONE Detection System AP Polymer (Ready-To-Use)
RICHARD-ALLAN SCIENTIFIC COMPANY
TL-125-ALJ
In Commercial Distribution

  • 00673693404976 ()

  • Total Volume: 125 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
UltraVision ONE Detection System HRP Polymer (Ready-To-Use)
RICHARD-ALLAN SCIENTIFIC COMPANY
TL-060-HLJ
In Commercial Distribution

  • 00673693404945 ()

  • Total Volume: 60 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
UltraVision ONE Detection System AP Polymer (Ready-To-Use)
RICHARD-ALLAN SCIENTIFIC COMPANY
TL-060-ALJ
In Commercial Distribution

  • 00673693404907 ()

  • Total Volume: 60 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
UltraVision ONE Detection System HRP Polymer (Ready-To-Use)
RICHARD-ALLAN SCIENTIFIC COMPANY
TL-015-HDJ
In Commercial Distribution

  • 00673693404877 ()

  • Total Volume: 15 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
UltraVision ONE Detection System AP Polymer (Ready-To-Use)
RICHARD-ALLAN SCIENTIFIC COMPANY
TL-015-AFJ
In Commercial Distribution

  • 00673693404815 ()

  • Total Volume: 15 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
One piece ECG cable for Emtel Compatible
Unimed Medical Supplies, Inc.
2322RP
In Commercial Distribution

  • 06936735468911 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for ZOLL Compatible
Unimed Medical Supplies, Inc.
C415-0093
In Commercial Distribution

  • 06936735468904 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for ZOLL Compatible
Unimed Medical Supplies, Inc.
C415-0092
In Commercial Distribution

  • 06936735468898 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Schiller Compatible
Unimed Medical Supplies, Inc.
10741
In Commercial Distribution

  • 06936735468874 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Schiller Compatible
Unimed Medical Supplies, Inc.
10735
In Commercial Distribution

  • 06936735468850 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Schiller Compatible
Unimed Medical Supplies, Inc.
10734
In Commercial Distribution

  • 06936735468843 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Medtronic Compatible
Unimed Medical Supplies, Inc.
10739
In Commercial Distribution

  • 06936735468836 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Medtronic Compatible
Unimed Medical Supplies, Inc.
10738
In Commercial Distribution

  • 06936735468829 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Schiller Compatible
Unimed Medical Supplies, Inc.
10737
In Commercial Distribution

  • 06936735468812 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Schiller Compatible
Unimed Medical Supplies, Inc.
10736
In Commercial Distribution

  • 06936735468805 ()


  • Electrocardiographic lead set, reusable
One® Stainless Steel Stethoscope, Infant, MDFBO
MDF Instruments Medifriend Inc.
MDF777IBO
In Commercial Distribution

  • 06940211620359 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF29
MDF Instruments Medifriend Inc.
MDF77729
In Commercial Distribution

  • 06940211620090 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF27
MDF Instruments Medifriend Inc.
MDF77727
In Commercial Distribution

  • 06940211620069 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF07
MDF Instruments Medifriend Inc.
MDF77707
In Commercial Distribution

  • 06940211620045 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF09
MDF Instruments Medifriend Inc.
MDF77709
In Commercial Distribution

  • 06940211619995 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF01
MDF Instruments Medifriend Inc.
MDF77701
In Commercial Distribution

  • 06940211619964 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDFBO
MDF Instruments Medifriend Inc.
MDF777BO
In Commercial Distribution

  • 06940211619957 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF17
MDF Instruments Medifriend Inc.
MDF77717
In Commercial Distribution

  • 06940211619940 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF11
MDF Instruments Medifriend Inc.
MDF77711
In Commercial Distribution

  • 06940211619933 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF04
MDF Instruments Medifriend Inc.
MDF77704
In Commercial Distribution

  • 06940211619919 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF32
MDF Instruments Medifriend Inc.
MDF77732
In Commercial Distribution

  • 06940211620106 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF08
MDF Instruments Medifriend Inc.
MDF77708
In Commercial Distribution

  • 06940211620076 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF23
MDF Instruments Medifriend Inc.
MDF77723
In Commercial Distribution

  • 06940211620052 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF14
MDF Instruments Medifriend Inc.
MDF77714
In Commercial Distribution

  • 06940211620014 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, MDF10
MDF Instruments Medifriend Inc.
MDF77710
In Commercial Distribution

  • 06940211619926 ()


  • Mechanical external stethoscope
Modified Navigation Mariner Screwdriver, One Forth Square
Seaspine Orthopedics Corporation
SR-0514
In Commercial Distribution

  • 10889981239602 ()
SR-0514

  • Orthopaedic implant driver
One piece ECG cable for SonoScape Compatible
Unimed Medical Supplies, Inc.
C2351P0
In Commercial Distribution

  • 06936735493890 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Bionet Compatible
Unimed Medical Supplies, Inc.
C2314P0
In Commercial Distribution

  • 06936735469420 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Emtel Compatible
Unimed Medical Supplies, Inc.
23111RP
In Commercial Distribution

  • 06936735468881 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Schiller Compatible
Unimed Medical Supplies, Inc.
10740
In Commercial Distribution

  • 06936735468867 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Spacelabs Compatible
Unimed Medical Supplies, Inc.
KL-21096S0
In Commercial Distribution

  • 06936735468270 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for Philips Compatible
Unimed Medical Supplies, Inc.
C25029P0
In Commercial Distribution

  • 06936735467785 ()


  • Electrocardiographic lead set, reusable
One piece ECG cable for DRE Compatible
Unimed Medical Supplies, Inc.
C2380P0
In Commercial Distribution

  • 06936735467549 ()


  • Electrocardiographic lead set, reusable
crown remover one handle, with two heads
Xinhua Surgical Instrument Co., Ltd.
ZR2241R
In Commercial Distribution

  • 06936506399864 ()


  • General-purpose surgical scissors, reusable
New Choice Plus One Step Pregnancy Test
SCI Medic, Inc.
00111
In Commercial Distribution

  • 00677421001116 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
2-Tier, 20-inst, Blue, one A/W Clip
HU-FRIEDY MFG. CO., LLC
IM9208AW
In Commercial Distribution

  • 10889950063740 ()


  • Device sterilization/disinfection container, reusable
BodyGuardian One 4G VZW Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-46
In Commercial Distribution



  • Medical networking interface unit
One Step Pregnancy (HCG) Urine Test Strip
MAXPERT MEDICAL
CPT01
Not in Commercial Distribution

  • 20852359007049 ()
  • 10852359007042 ()
  • 00852359007045 ()
CPT01

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
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