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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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Luxisse - 00817724020654

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
G
In Commercial Distribution

  • 00817724020654 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK 3740HT14 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020647

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
G
In Commercial Distribution

  • 00817724020647 ()

  • Height: 12 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK 3740HT12 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020630

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
G
In Commercial Distribution

  • 00817724020630 ()

  • Height: 10 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK 3740HT10 T

  • Dental appliance fabrication material, ceramic

PIEZON - 07613353002572

Universal Piezon Handpiece
E.M.S. Electro Medical Systems S.A.
g
In Commercial Distribution

  • 07613353002572 ()
EN-041

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353002510

Instrument PS
E.M.S. Electro Medical Systems S.A.
g
In Commercial Distribution

  • 07613353002510 ()
DS-016

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

PIEZON - 07613353056674

Footpedal
E.M.S. Electro Medical Systems S.A.
g
In Commercial Distribution

  • 07613353056674 ()
EH-004

  • Foot-switch, electrical

PIEZON - 07613353178116

Piezon Handpiece
E.M.S. Electro Medical Systems S.A.
G
In Commercial Distribution

  • 07613353178116 ()
EN-061/A

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353141363

miniMaster
E.M.S. Electro Medical Systems S.A.
G
In Commercial Distribution

  • 07613353141363 ()
FT-155#A/026

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353141127

miniMaster
E.M.S. Electro Medical Systems S.A.
G
In Commercial Distribution

  • 07613353141127 ()
FT-155#A

  • Ultrasonic dental scaling/debridement system

Richardson Electronics - G252430017660

HEAT EXCHANGER, G
Richardson Electronics, Ltd.
G
In Commercial Distribution

  • G252430017660 ()
RELL43001766

  • X-ray system tube

ShangRing - 16939550822309

ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
G
In Commercial Distribution

  • 26939550822306 ()
  • 16939550822309 ()
  • 86939550822308 ()


  • Surgical penis clamp, single-use

IFA: Legionella Mosaic 4 (IgAGM) - 04049016105947

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-2005-4 P
Not in Commercial Distribution

  • 04049016105947 ()


  • Multiple Legionella species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

IFA: Legionella Mosaic 4 (IgAGM) - 04049016105923

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1005-4 P
Not in Commercial Distribution

  • 04049016105923 ()


  • Multiple Legionella species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

IFA: Legionella Mosaic 4 (IgAGM) - 04049016105930

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1010-4 P
Not in Commercial Distribution

  • 04049016105930 ()


  • Multiple Legionella species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Legionella non-pneumophila (IgAGM) - 04049016085164

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 216f-1005-1 P
Not in Commercial Distribution

  • 04049016085164 ()


  • Multiple Legionella species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

biokitHSV-2 - 08426951056439

20 Test Devices 20 x 0,7 ml Sample Diluent 20 x 0,5 ml Developing Reagent 20 x Empty Vials 1 20 x Pre-filter tips 20 x Capillary tubes 20 x Lancets 20 x Swabs 20 x Tube racks
BIOKIT, S.A.
300028001
Not in Commercial Distribution

  • 08426951056439 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Kalazar Detect Rapid Test for Visceral Leishmaniasis - B379INS0251

No Description
INBIOS INTERNATIONAL, INC
INS025
In Commercial Distribution

  • B379INS0251 ()
INS025

  • Leishmania donovani immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Chagas Detect™ Plus Rapid Test - B379CP0501

No Description
INBIOS INTERNATIONAL, INC
CP050
In Commercial Distribution

  • B379CP0501 ()
CP050

  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

SAS Herpes Check Test - 00780311000134

SAS Herpes Check lateral flow test kit is a visual and rapid assay for the qualitative detection of Herpes Simplex Virus Types 1 & 2 antigens in the eye and genital vesicular fluid.
SA SCIENTIFIC, LTD.
062002-W
In Commercial Distribution

  • 00780311000134 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Tubigrip® - 05055158005488

Tubigrip G Natural 0.5m 7x12pcs
Mölnlycke Health Care AB
1515
In Commercial Distribution

  • 07332551943714 ()
  • 05055158005495 ()
  • 05055158005488 ()

  • G


  • Tubular support bandage, Hevea-latex
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