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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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Pole to assist the patient to raise the body from Hospital Bed.
PARAMOUNT BED CO., LTD.
KA-H70LU
In Commercial Distribution

  • 04527799700271 ()


  • Assistive patient lifting pole
R25 to MP Adapter Cable 25 Pin to 8 Pin Adapter Cable
MASIMO CORPORATION
4468
In Commercial Distribution

  • 00843997013840 ()


  • Electrical-only medical device connection cable, reusable
Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510685 ()


  • Red/blue light phototherapy unit
used to apply controlled temperature to a specific part of the body.
Saringer Life Science Technologies Inc
cold
Not in Commercial Distribution

  • 00683601000077 ()


  • Electric pad localized-body heating system
Monopolar connection Umax: 4,3kVcable to laparoscopic instruments5m long to Hermann, Martin, Berchtoldunits
Hermann Medizintechnik GmbH
H98-903-050
In Commercial Distribution

  • 04059453026767 ()


  • Electrical-only medical device connection cable, reusable
This applies to minor versions referred to as v2018, v2023, v2024, v2025
INVIA LLC
C4DM10
In Commercial Distribution

  • 00864974000257 ()


  • Radiology DICOM image processing application software
1-Step Silane primer applied to porcelain dental restorations for bonding to teeth.
CAO GROUP, INC.
006-00078
In Commercial Distribution

  • 00872320000509 ()
  • 00872320002992 ()
006-00078

  • Dentine bonding agent/set
40.5 mm threaded magnetic ring to attach compatible DL to Nikon 1
DermLite LLC
DLMC-N1
In Commercial Distribution

  • 00850017651067 ()
DLMC-N1

  • Dermatoscope, optical
Device to retract the lips/cheeks to facilitate viewing of the teeth.
STRAIGHT SMILE LLC
BSS1
In Commercial Distribution

  • 00850017524002 ()


  • Dental cheek retractor, home-use
Attaches to both inserters to hold counter torque when actuating lock tool.
Curvafix Inc
CHW-001-LP
In Commercial Distribution

  • 10850070500569 ()
CHW-001-LP

  • Surgical torque wrench, reusable
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