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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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No Description
UTAK LABORATORIES, INC.
U QC LOW EL
In Commercial Distribution

  • B80001390500011 ()
  • B80001390500010 ()
  • B80001390500012 ()
  • B80001390500013 ()
  • B80001390500016 ()
  • B80001390500017 ()
  • B80001390500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
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
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
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
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
MAC Charger
Recovery Force, LLC
B
In Commercial Distribution

  • B547RF14300 ()
  • B547RF1440237 ()
  • B547RF1440207 ()
  • B547RF1440217 ()
  • B547RF1440227 ()
  • B547RF143009 ()

  • Length: 203 Millimeter
RF1430

  • Intermittent venous compression system
272 micrometer ScopeSafe™ Laser Fiber with SoftTip™
OPTICAL INTEGRITY INC
11613
In Commercial Distribution

  • B145116130 ()
  • B145116135 ()
  • B145116131 ()
  • B145116831 ()
  • B145116150 ()
  • B145116171 ()

  • Outer Diameter: 272 Micrometer
SU-200-ST

  • General/multiple surgical laser system beam guide, reusable
A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.
NOVOSCI CORP.
201005NS
In Commercial Distribution

  • B066201005NS6 ()
  • B066201005NS1 ()
  • B066201005NS5 ()
  • B066201005NS4 ()
  • B066201005NS3 ()
  • B066201005NS2 ()
  • B066201005NS0 ()
201005NS

  • Body aspiration needle, single-use
A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.
NOVOSCI CORP.
000325-011NS
In Commercial Distribution

  • B066000325011NS6 ()
  • B066000325011NS1 ()
  • B066000325011NS5 ()
  • B066000325011NS4 ()
  • B066000325011NS3 ()
  • B066000325011NS2 ()
  • B066000325011NS0 ()
000325-011NS

  • Luer-formatted protective cap
ScanX Intraoral for Centralized 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.
F3605
In Commercial Distribution

  • D678F36050 ()
  • D678F36001 ()
  • D678F3600U1 ()
  • D678F36051 ()
  • D678F3600C1 ()

  • Height: 16 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 44 Pound
F3600

  • Radiography digital imaging scanner
Alginate Alternative Fast Set 50ml. Cartridges 8/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
9012
In Commercial Distribution

  • D7969012 ()
  • D79690121 ()
  • D79690122 ()
  • D79690123 ()
  • D79690124 ()
  • D79690125 ()
9012

  • Silicone dental impression material
Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
MRIAUDIO, INC.
302
In Commercial Distribution

  • B6693020 ()
  • B6693501 ()
  • B6693251 ()
  • B6693011 ()
  • B6693001 ()
302

  • Headphones
MAC Controller
Recovery Force, LLC
H
In Commercial Distribution

  • B547RF14100 ()
  • B547RF144020 ()
  • B547RF144021 ()
  • B547RF144022 ()
  • B547RF1440230 ()

  • Length: 136 Millimeter
RF1410

  • Intermittent venous compression system
Male to Male Luer Adapter
MOLDED PRODUCTS, INC.
MPC-150
In Commercial Distribution

  • B144MPC1503 ()
  • B144MPC1502 ()
  • B144MPC1501 ()
  • B144MPC1500 ()
  • B144MPC1504 ()
MPC-150

  • Haemodialysis blood tubing set, single-use
Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-125Y
In Commercial Distribution

  • B144MPC125Y3 ()
  • B144MPC125Y2 ()
  • B144MPC125Y1 ()
  • B144MPC125Y0 ()
  • B144MPC125Y4 ()
MPC-125Y

  • Luer-formatted disinfection cap
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