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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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7-AMINO PLUS 100 NG/ML
UTAK LABORATORIES, INC.
7-AMINO+ 100 MP
In Commercial Distribution

  • B80000357500031 ()
  • B80000357500030 ()
  • B80000357500032 ()
  • B80000357500033 ()
  • B80000357500036 ()
  • B80000357500037 ()
  • B80000357500038 ()


  • Benzodiazepine group IVD, control
DAU +25% GCMS
UTAK LABORATORIES, INC.
DAU +25 GCMS
In Commercial Distribution

  • B80000357500021 ()
  • B80000357500020 ()
  • B80000357500022 ()
  • B80000357500023 ()
  • B80000357500026 ()
  • B80000357500027 ()
  • B80000357500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
DAU -25% GCMS
UTAK LABORATORIES, INC.
DAU -25 GCMS
In Commercial Distribution

  • B80000357500011 ()
  • B80000357500010 ()
  • B80000357500012 ()
  • B80000357500013 ()
  • B80000357500016 ()
  • B80000357500017 ()
  • B80000357500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
A non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device.
NOVOSCI CORP.
102357NS
In Commercial Distribution

  • B066102357NS1 ()
  • B066102357NS7 ()
  • B066102357NS6 ()
  • B066102357NS5 ()
  • B066102357NS4 ()
  • B066102357NS3 ()
  • B066102357NS2 ()
  • B066102357NS0 ()
102357NS

  • Non-ISO80369-standardized small-bore linear connector, single-use
ScanX Classic for Intraoral & Extraoral Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3705
In Commercial Distribution

  • D678F37050 ()
  • D678F37001 ()
  • D678F3700U1 ()
  • D678F37051 ()
  • D678F3700C1 ()
  • D678F3750C1 ()
  • D678F37501 ()

  • Height: 24.5 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 51 Pound


  • Radiography digital imaging scanner
ELECTRODE PADS
BEAR DOWN CONSULTING
PETENSPAD
In Commercial Distribution

  • B311PETENSPAD5 ()
  • B311PETENSPAD0 ()
  • B311PETENSPAD4 ()
  • B311PETENSPAD3 ()
  • B311PETENSPAD2 ()
  • B311PETENSPAD1 ()
  • B311PETENSPAD6 ()


  • Transcutaneous electrical stimulation electrode, single-use
PACK OF ELECTRODES
BEAR DOWN CONSULTING
PEPROPAD
In Commercial Distribution

  • B311PEPROPAD0 ()
  • B311PEPROPAD4 ()
  • B311PEPROPAD3 ()
  • B311PEPROPAD2 ()
  • B311PEPROPAD1 ()
  • B311PEPROPAD5 ()
  • B311PEPROPAD6 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B30001346000010 ()
  • B30001346000011 ()
  • B30001346000012 ()
  • B30001346000013 ()
  • B30001346000016 ()
  • B30001346000017 ()
  • B30001346000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes.
DAXOR CORPORATION
MAX-100 Syringe
In Commercial Distribution

  • B641MAX1004 ()
  • B641MAX1002 ()
  • B641MAX1000 ()
  • B641MAX1003 ()
  • B641MAX1001 ()
  • B641MAX1005 ()


  • Metered-delivery hypodermic syringe
No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOFLUX101 ()
  • B635BIOFLUX100 ()
  • B635BIOFLUX105 ()
  • B635BIOFLUX104 ()
  • B635BIOFLUX103 ()
  • B635BIOFLUX102 ()


  • Electrocardiography telemetric monitoring system transmitter
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