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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VITA ENAMIC IS, 3M2-HT, IS-16S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM4209365
In Commercial Distribution

  • J017EC4EM42093650 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 2M2-HT, IS-16L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM4129485
In Commercial Distribution

  • J017EC4EM41294850 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 2M2-HT, IS-16S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM4129365
In Commercial Distribution

  • J017EC4EM41293650 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M2-HT, IS-16L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM4079485
In Commercial Distribution

  • J017EC4EM40794850 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M2-HT, IS-16S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM4079365
In Commercial Distribution

  • J017EC4EM40793650 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M1-HT, IS-16L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM4069485
In Commercial Distribution

  • J017EC4EM40694850 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M1-HT, IS-16S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM4069365
In Commercial Distribution

  • J017EC4EM40693650 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 4M2-T, IS-14L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3289725
In Commercial Distribution

  • J017EC4EM32897250 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 4M2-T, IS-14S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3289605
In Commercial Distribution

  • J017EC4EM32896050 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 3M2-T, IS-14L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3209725
In Commercial Distribution

  • J017EC4EM32097250 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 3M2-T, IS-14S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3209605
In Commercial Distribution

  • J017EC4EM32096050 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 2M2-T, IS-14L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3129725
In Commercial Distribution

  • J017EC4EM31297250 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 2M2-T, IS-14S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3129605
In Commercial Distribution

  • J017EC4EM31296050 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M2-T, IS-14L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3079725
In Commercial Distribution

  • J017EC4EM30797250 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M2-T, IS-14S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3079605
In Commercial Distribution

  • J017EC4EM30796050 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M1-T, IS-14L, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3069725
In Commercial Distribution

  • J017EC4EM30697250 ()


  • Dental appliance fabrication material, ceramic
VITA ENAMIC IS, 1M1-T, IS-14S, 5 pcs.
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
EC4EM3069605
In Commercial Distribution

  • J017EC4EM30696050 ()


  • Dental appliance fabrication material, ceramic
Speech Generating Device with Eyegaze (IS 20)
TOBII DYNAVOX LLC
I-12+ IS20
Not in Commercial Distribution

  • 07340074600267 ()


  • Voice synthesizer/digitizer
The Footswitch is an accessory of Exceed.
MT.DERM GmbH
E104201USMP
In Commercial Distribution

  • EMTDE104201USMP0 ()
  • EMTDE104201USMP1 ()


  • Cosmetic micro-needling electronic handpiece, professional
Single-Use Video Bronchoscope:Maximum insertion portion width is 4.4mm, minimum instrument channel width is 1.2mm,working length 600mm.
Micro-Tech (Nanjing) Co., Ltd.
SVB11001
In Commercial Distribution

  • 16932503571118 ()
  • 06932503571111 ()
  • 26932503571115 ()

  • Outer Diameter: 4.4 Millimeter
  • Pore Size: 1.2 Millimeter
  • Catheter Working Length: 600 Millimeter


  • Flexible video bronchoscope, single-use
The Nanodropper B14 is an eye drop bottle adaptor. The Nanodropper B14 is for single-bottle use only.
NANODROPPER, INC.
B14
In Commercial Distribution

  • 00860003576137 ()
  • 00860003576120 ()
LUNA-B14

  • Eye dropper bottle nozzle adaptor
The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-50
In Commercial Distribution

  • 00857377006162 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-35
In Commercial Distribution

  • 00857377006155 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The Replacement Pad Set is used with PowerLift Freedom Stirrups (pair) - Bariatric 800 pound is used with
STERIS CORPORATION
Stirrup Pad
In Commercial Distribution

  • 00724995217273 ()
BF866

  • Heel stirrup cushion/pad, reusable
The Replacement Pad Set is used with PowerLift Freedom Stirrups (pair) - Adult 500 pound is used with
STERIS CORPORATION
Stirrup Pad
In Commercial Distribution

  • 00724995217259 ()
BF864

  • Heel stirrup cushion/pad, reusable
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software
SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450050
In Commercial Distribution

  • D010644500501 ()

  • Length: 7.5 Centimeter
64450050

  • Dental/surgical polymerization lamp
SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450021
In Commercial Distribution

  • D010644500211 ()

  • Length: 5.9 Centimeter
64450021

  • Dental/surgical polymerization lamp
Light. This is sold as part of the 11-Unit Package (688203) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
In Commercial Distribution

  • D0019882980 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A2-A3-A3-A3.5)
Meta Biomed Co., Ltd.
9499
In Commercial Distribution

  • 08806387894995 ()


  • Dental composite resin
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A1-A1-A2-A2-A3)
Meta Biomed Co., Ltd.
9498
In Commercial Distribution

  • 08806387894988 ()


  • Dental composite resin
Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform.
Meta Biomed Co., Ltd.
9325
In Commercial Distribution

  • 08806387893257 ()


  • Endodontic temporary cement
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A3-A3.5-B2-B3)
Meta Biomed Co., Ltd.
6001
In Commercial Distribution

  • 08806387860013 ()


  • Dental composite resin
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A3-A3-A3.5-A3.5)
Meta Biomed Co., Ltd.
6000
In Commercial Distribution

  • 08806387860006 ()


  • Dental composite resin
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
17525-10
In Commercial Distribution

  • 08718755001150 ()


  • Solid-state-semiconductor radiation measuring probe
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
16759-10
In Commercial Distribution

  • 08718755001143 ()


  • Solid-state-semiconductor radiation measuring probe
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14207-10
In Commercial Distribution

  • 08718755001136 ()


  • Solid-state-semiconductor radiation measuring probe
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14098-10
In Commercial Distribution

  • 08718755001129 ()


  • Solid-state-semiconductor radiation measuring probe
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14063-10
In Commercial Distribution

  • 08718755001112 ()


  • Solid-state-semiconductor radiation measuring probe
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