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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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BIOTRICITY INC
1.0
In Commercial Distribution

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


  • Electrocardiography telemetric monitoring system transmitter
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
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
Light curing composite for the production of individual impression trays and base plates
MEGADENTA Dentalprodukte GmbH
2022/11/05
In Commercial Distribution

  • EMD11MYDVOKRS1 ()
  • EMD11MYDVOKS2 ()
  • EMD11MYDVOKBL1 ()
  • EMD11MYDVOKTR1 ()
  • EMD11MYDVOKRS11 ()


  • Dental impression tray material
The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250AN
In Commercial Distribution

  • B994SC250AN0 ()
  • B994SC250AN2 ()
  • B994SC250AN6 ()
  • B994SC250AN8 ()
  • B994SC250AN4 ()

  • Total Volume: 0.25 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
SC250AN

  • General-purpose syringe/needle
The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250
Not in Commercial Distribution

  • B994SC2501 ()
  • B994SC2500 ()
  • B994SC2503 ()
  • B994SC2505 ()
  • B994SC2502 ()

  • Total Volume: 0.25 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
SC250

  • General-purpose syringe/needle
MAC Controller
Recovery Force, LLC
H
In Commercial Distribution

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

  • Length: 136 Millimeter
RF1410

  • Intermittent venous compression system
Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
MRIAUDIO, INC.
302
In Commercial Distribution

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

  • Headphones
Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack
CELLERA LLC
20267
Not in Commercial Distribution

  • B492202673 ()
  • B492202671 ()
  • B492202670 ()
  • B492202672 ()
  • B49220673 ()
20267

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
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