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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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LINE, ARTERIAL FILTER PURGE - B0662010080000

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
NOVOSCI CORP.
201008-000
In Commercial Distribution

  • B0662010080000 ()
  • B0662010080007 ()
  • B0662010080006 ()
  • B0662010080005 ()
  • B0662010080003 ()
201008-000

  • Cardiopulmonary bypass system filter, arterial blood line

NEEDLE, AIR ASPIRATOR 16 GA W/BLUE CAP - B0662010050000

A sterile, 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. This is a single-use device.
NOVOSCI CORP.
201005-000
In Commercial Distribution

  • B0662010050006 ()
  • B0662010050000 ()
  • B0662010050005 ()
  • B0662010050004 ()
  • B0662010050003 ()
201005-000

  • Body aspiration needle, single-use

Naturelle - B3402517650

Individually packaged tampon
IMPACT PRODUCTS, LLC
251765
In Commercial Distribution

  • B34025160273 ()
  • B3402517650 ()
  • B34025176488 ()
  • B340A25176598 ()
  • B34025160275 ()


  • Menstrual tampon, unscented

ScanX Intraoral for Centralized Imaging - D678F36050

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

StaClear - B994SC250AN0

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

StaClear - B994SC2500

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

MRIaudio Ear-Tip - B6693020

Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
MRIAUDIO, INC.
302
In Commercial Distribution

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

  • Headphones

Movement and Compressions System (MAC) - B547RF14100

MAC Controller
Recovery Force, LLC
H
In Commercial Distribution

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

  • Length: 136 Millimeter
RF1410

  • Intermittent venous compression system

MARK3 - D79690121

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

MARK3 - D79611511

eXact VPS 380 Impression Material Heavy Body Fast Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
1151
In Commercial Distribution

  • D79611512D79611511 ()
  • D79611511 ()
  • D79611512 ()
  • D79611513 ()
  • D79611514 ()
  • D79611515 ()
1151

  • Silicone dental impression material
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