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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Massager, Therapeutic, Electric, heated
ShenZhen Pentasmart Technology Co,.Ltd
uLumb-6533B
In Commercial Distribution

  • 06974581810164 ()


  • Hand-held electric massager
Massager, Therapeutic, Electric, heated
ShenZhen Pentasmart Technology Co,.Ltd
uAngel-6532B
In Commercial Distribution

  • 06974581810157 ()


  • Hand-held electric massager
Massager, Therapeutic, Electric, heated
ShenZhen Pentasmart Technology Co,.Ltd
uLook -6512B
In Commercial Distribution

  • 06974581810133 ()


  • Hand-held electric massager
Massager, Therapeutic, Electric, heated
ShenZhen Pentasmart Technology Co,.Ltd
uLook-6511B
In Commercial Distribution

  • 06974581810126 ()


  • Hand-held electric massager
Massager, Therapeutic, Electric, heated
ShenZhen Pentasmart Technology Co,.Ltd
uLook-6510B
In Commercial Distribution

  • 06974581810119 ()


  • Hand-held electric massager
Massager, Therapeutic, Electric, heated
ShenZhen Pentasmart Technology Co,.Ltd
uIdea-6501B
In Commercial Distribution

  • 06974581810096 ()


  • Hand-held electric massager
Massager, Therapeutic, Electric, heated
ShenZhen Pentasmart Technology Co,.Ltd
uIdea-6500B
In Commercial Distribution

  • 06974581810089 ()


  • Hand-held electric massager
The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
NORTH EAST SCIENTIFIC INC
CF7-7-100
In Commercial Distribution


  • Heating Element Size: 7 Centimeter
  • Length: 100 Centimeter
  • Lumen/Inner Diameter: 0.025 Inch
R-CF7-7-100

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-60) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
NORTH EAST SCIENTIFIC INC
CF7-7-60
In Commercial Distribution


  • Heating Element Length: 7 Centimeter
  • Length: 60 Centimeter
  • Lumen/Inner Diameter: 0.025 Inch
R-CF7-7-60

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-3-60) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
NORTH EAST SCIENTIFIC INC
CF7-3-60
In Commercial Distribution


  • Catheter Working Length: 60 Centimeter
  • Heating element Length: 3 Centimeter
  • Lumen/Inner Diameter: 0.025 Inch
R-CF7-3-60

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
No Description
Biobase Biodustry(Shandong)Co., Ltd.
BK-HW60
In Commercial Distribution

  • 06936895301349 ()


  • General-purpose thermostat
No Description
Biobase Biodustry(Shandong)Co., Ltd.
BK-HW100D
In Commercial Distribution

  • 06936895301325 ()


  • General-purpose thermostat
No Description
Biobase Biodustry(Shandong)Co., Ltd.
BK-HW100G
In Commercial Distribution

  • 06936895301332 ()


  • General-purpose thermostat
No Description
Biobase Biodustry(Shandong)Co., Ltd.
BK-HW100
In Commercial Distribution

  • 06936895301318 ()


  • General-purpose thermostat
VERIFY 6 Well Incubator, 55-60 Degree Celsius, are specially designed for use with VERIFY Biological Indicators.
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995095659 ()
S3271

  • Test tube heater
Incubator, 56 Degree Celsius Adjusts 30-60 Degree Celsius with Thermometer used with indicators for Liquid Chemical Processing Systems.
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995030926 ()
C1392

  • Test tube heater
VERIFY 28 well and 6 well 55-60 Degree Celsius Incubator fits individual facility incubation needs and are specially designed for use with VERIFY Biological Indicators.
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995023935 ()
S3082

  • Test tube heater
VERIFY Large Dual Incubator is specially designed for use with VERIFY Biological Indicators.
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995023928 ()
S3081

  • Test tube heater
VERIFY Dual Temperature 28 well incubator allows incubation at two different temperatures in one incubator
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995023911 ()
S3080

  • Test tube heater
The FIBRINOTHERM Heating and Stirring Device is designed to facilitate the reconstitution of Baxter's two component Fibrin Sealant kit. The device consists of a heating block and an integrated magnetic stirrer.
BAXTER INTERNATIONAL INC.
0600047
In Commercial Distribution

  • 55413760308376 ()
  • 05413760308371 ()
0600047

  • Laboratory shaker
ThermoBrite Elite automates protocols for FISH testing of pathology specimens mounted on microscope slides. ThermoBrite Elite fully automates pre and post hybridization steps while providing temperature control for on-board denaturation and hybridization. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
3800-007000-001
In Commercial Distribution

  • 09349458005443 ()
3800-007000-001

  • Microscope slide hybridization/denaturation incubator IVD
No Description
Leica Biosystems Richmond, Inc.
3800-004852-004
In Commercial Distribution

  • 00849832002109 ()

  • Device Size Text, specify:


  • Microscope slide hybridization/denaturation incubator IVD
No Description
Leica Biosystems Richmond, Inc.
3800-004852-003
In Commercial Distribution

  • 00849832002093 ()

  • Device Size Text, specify:


  • Microscope slide hybridization/denaturation incubator IVD
No Description
Leica Biosystems Richmond, Inc.
3800-004852-002
In Commercial Distribution

  • 00849832002086 ()

  • Device Size Text, specify:


  • Microscope slide hybridization/denaturation incubator IVD
No Description
Leica Biosystems Richmond, Inc.
3800-004852-001
In Commercial Distribution

  • 00849832002079 ()

  • Device Size Text, specify:


  • Microscope slide hybridization/denaturation incubator IVD
No Description
NanoEnTek, Inc.
F10AP
In Commercial Distribution

  • 08809317540467 ()


  • Heating block IVD
No Description
LCR HALLCREST, LLC.
9000
In Commercial Distribution

  • 10815236020923 ()
  • 00815236020926 ()
  • M74490000 ()


  • Heating block IVD
Quidel Digital Heat Block - 230V
DIAGNOSTIC HYBRIDS, INC.
M222
In Commercial Distribution

  • 30014613336976 ()
M222

  • Heating block IVD
Quidel Digital Heat Block
DIAGNOSTIC HYBRIDS, INC.
M221
In Commercial Distribution

  • 30014613336969 ()
M221

  • Heating block IVD
AmpliVue 95 Heatblock 230V
DIAGNOSTIC HYBRIDS, INC.
M218
In Commercial Distribution

  • 30014613336051 ()
M218

  • Heating block IVD
AmpliVue 95 Heatblock Set
DIAGNOSTIC HYBRIDS, INC.
M217
In Commercial Distribution

  • 30014613336044 ()
M217

  • Heating block IVD
AmpliVue 64 Heatblock Set
DIAGNOSTIC HYBRIDS, INC.
M215
In Commercial Distribution

  • 30014613312154 ()
M215

  • Heating block IVD
AmpliVue Heatblock Insert
DIAGNOSTIC HYBRIDS, INC.
M214
In Commercial Distribution

  • 30014613312147 ()
M214

  • Heating block IVD
No Description
BIOSYNERGY, INC.
9000
Not in Commercial Distribution

  • M74490001 ()
  • M74490000 ()


  • Heating block IVD
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
CHB-T2-C
In Commercial Distribution

  • 06973843221069 ()


  • Heating block IVD
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
CHB-T2-B
In Commercial Distribution

  • 06973843221052 ()


  • Heating block IVD
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
CHB-T1-E
In Commercial Distribution

  • 06973843221038 ()


  • Heating block IVD
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
CHB-T1-D
In Commercial Distribution

  • 06973843221021 ()


  • Heating block IVD
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
CHB-T1-C
In Commercial Distribution

  • 06973843221014 ()


  • Heating block IVD
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
CHB-T1-B
In Commercial Distribution

  • 06973843221007 ()


  • Heating block IVD
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