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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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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

Megatray - EMD11MYDVOKS2

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

Vitale - B492202670

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

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

Naturelle - B3402517650

Individually packaged tampon
IMPACT PRODUCTS, LLC
251765
In Commercial Distribution

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


  • Menstrual tampon, unscented

Easy Glide 20cc Luer Lock Syringe - B2086720200

Easy Glide 20cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
672020
In Commercial Distribution

  • B2086720203 ()
  • B2086720201 ()
  • B2086720200 ()
  • B2086720204 ()
  • B2086720205 ()


  • General-purpose syringe, single-use

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

CRYOLOCK(Y) - B056CLRCTY1

Cryolock - Yellow Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(Y)
In Commercial Distribution

  • B056CLRCTY5 ()
  • B056CLRCTY2 ()
  • B056CLRCTY1 ()
  • B056CLRCTY0 ()
  • B056CLRCTY3 ()
  • B056CLRCTY7 ()
CL-R-CT (Yellow)

  • Assisted reproduction vitrification carrier

CRYOLOCK(O) - B056CLRCTO1

Cryolock - Orange Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(O)
In Commercial Distribution

  • B056CLRCTO5 ()
  • B056CLRCTO2 ()
  • B056CLRCTO1 ()
  • B056CLRCTO0 ()
  • B056CLRCTO3 ()
  • B056CLRCTO7 ()
CL-R-CT (Orange)

  • Assisted reproduction vitrification carrier

Cryolock(G) - B056CLRCTG1

Cryolock - Green Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(G)
In Commercial Distribution

  • B056CLRCTG2 ()
  • B056CLRCTG1 ()
  • B056CLRCTG0 ()
  • B056CLRCTG5 ()
  • B056CLRCTG3 ()
  • B056CLRCTG7 ()
CL-R-CT (Green)

  • Assisted reproduction vitrification carrier
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