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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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Portable LED facial device
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1696B
In Commercial Distribution

  • 06971024921258 ()


  • Blue/red/infrared phototherapy lamp
No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1696A
In Commercial Distribution

  • 06971024921241 ()


  • Blue/red/infrared phototherapy lamp
No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1611B
In Commercial Distribution

  • 06971024921135 ()


  • Blue/red/infrared phototherapy lamp
The Lumaflex Panel (Model: ZLD-05A) is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. CLOSE
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZLD-05A
In Commercial Distribution

  • 06970006971649 ()


  • Red/infrared light phototherapy unit
The Lumaflex Panel (Model: ZLD-05) is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZLD-05
In Commercial Distribution

  • 06970006971038 ()


  • Red/infrared light phototherapy unit
Red Light Therapy Lamp
Dongguan Tiger&Rose Technology Limited
1019359
Not in Commercial Distribution

  • 06978725510071 ()


  • Red/infrared light phototherapy unit
The CurrentBody Skin LED Neck& Décolletage Mask is powered by 3 highly precise LED wavelengths, proven in scientific testing to be most effective for anti-ageing and skin rejuvenation.
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
ZLD-110A
In Commercial Distribution

  • 00731093154485 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
Meditech International Inc
MCU I-P
In Commercial Distribution

  • B271MCUIP0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
MCU I-H
In Commercial Distribution

  • B271MCUIH0 ()


  • Red-light phototherapy unit, professional
No Description
Merchsource, LLC
1019359
In Commercial Distribution

  • 00840397513390 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen YHLO Biotech Co., Ltd.
I-UNICELL
In Commercial Distribution

  • 06925912711049 ()
I6101

  • Microplate/tube/assay card incubator IVD
The Procleix Xpress® System v2.0 (Software and instrument) is intended to be used to create whole blood lysates and pools of whole blood lysates for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 2.0
In Commercial Distribution

  • 00866489000029 ()
740807

  • Pipetting system
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of  human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution

  • 00866489000036 ()
740769

  • Pipetting system
DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
DIAGNOSTIC GRIFOLS SA
213734
In Commercial Distribution

  • 08437014205169 ()
213734

  • Microplate/tube/assay card incubator IVD
IPS
BIO-RAD
87530
In Commercial Distribution

  • 03610520014103 ()

  • 1 each
87530

  • Microplate/tube/assay card incubator IVD
Incubator, KVM Model 120, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
934090F
In Commercial Distribution

  • 10758750005352 ()
934090F

  • Microplate/tube/assay card incubator IVD
LSU003 LifeStart with Gas Cylinder Holder and Basket
INSPIRATION HEALTHCARE LIMITED
LSU003
In Commercial Distribution

  • 05060206922259 ()


  • Infant resuscitation table
Extended LifeStart LSU002
INSPIRATION HEALTHCARE GROUP PLC
LSU002
In Commercial Distribution

  • 05060195340690 ()


  • Infant resuscitation table
Compact LifeStart LSU001
INSPIRATION HEALTHCARE GROUP PLC
LSU001
In Commercial Distribution

  • 05060195340683 ()


  • Infant resuscitation table
No Description
Hamilton Bonaduz AG
185082
In Commercial Distribution

  • 07630032600027 ()


  • Pipetting system
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