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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 Classic for Intraoral & Extraoral Imaging - D678F37050

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

RED Prep-Kit - B960RED202

The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of five (5) cartons and is to be used with the NeurAxis RED (PN 02-2050, UDI: B960RED201) device. Each of the five cartons contains the following items: 1) One (1) pack of Extra-Large Heavy Absorbency Disposable Under-pads. Medline, MSC282070LB or similar. Product Code LRO. 2) Two (2) tubes of single use Lubricating Jelly. Medline, MDS032280 or similar. Product Code KMJ. 3) Two (2) packs of 10/hard tray Woven Sterile Gauze Sponges 4"x4", 12-ply. Medline, NON21426 or similar. Product Code EFQ. 4) One (1) pack of five (5) Ready Bath Select Bathing cloths 8x8 inch. Medline, MSC095109 or similar. Product Code KKX. 5) One (1) Sterile Skin Marker with Ruler. Medline, DYNJSM01 or similar. Product Code FTY. 6) One Instructions For Use [IFU] (LBL6014). Minimum 1 IFU/Box.
Neuraxis, Inc.
02 2051 RED
In Commercial Distribution

  • B960RED202 ()
  • B960RED2020 ()
  • B960RED2021 ()
  • B960RED2022 ()
  • B960RED2023 ()
  • B960RED2024 ()
  • B960RED2025 ()
02-2051

  • General surgical procedure kit, non-medicated, single-use

DRUGS OF ABUSE +50% - B80004644000010

DRUGS OF ABUSE +50%
UTAK LABORATORIES, INC.
DAU SCR +50 SAFE
In Commercial Distribution

  • B80004644000011 ()
  • B80004644000010 ()
  • B80004644000012 ()
  • B80004644000013 ()
  • B80004644000016 ()
  • B80004644000017 ()
  • B80004644000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU QC HIGH V4 - B80004240000090

No Description
UTAK LABORATORIES, INC.
DAU QC H V4 SEMCE
In Commercial Distribution

  • B80004240000090 ()
  • B80004240000091 ()
  • B80004240000092 ()
  • B80004240000093 ()
  • B80004240000096 ()
  • B80004240000097 ()
  • B80004240000098 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU QC MID V4 - B80004240000080

No Description
UTAK LABORATORIES, INC.
DAU QC M V4 SEMCE
In Commercial Distribution

  • B80004240000080 ()
  • B80004240000081 ()
  • B80004240000082 ()
  • B80004240000083 ()
  • B80004240000086 ()
  • B80004240000087 ()
  • B80004240000088 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU QC LOW V4 - B80004240000070

No Description
UTAK LABORATORIES, INC.
DAU QC L V4 SEMCE
In Commercial Distribution

  • B80004240000070 ()
  • B80004240000071 ()
  • B80004240000072 ()
  • B80004240000073 ()
  • B80004240000076 ()
  • B80004240000077 ()
  • B80004240000078 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU CALIBRATOR LEVEL 6 - B80004240000060

No Description
UTAK LABORATORIES, INC.
DAU CAL 6 V4 F SEMCE
In Commercial Distribution

  • B80004240000060 ()
  • B80004240000061 ()
  • B80004240000062 ()
  • B80004240000063 ()
  • B80004240000066 ()
  • B80004240000067 ()
  • B80004240000068 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU CALIBRATOR LEVEL 5 - B80004240000050

No Description
UTAK LABORATORIES, INC.
DAU CAL 5 V4 F SEMCE
In Commercial Distribution

  • B80004240000050 ()
  • B80004240000051 ()
  • B80004240000052 ()
  • B80004240000053 ()
  • B80004240000056 ()
  • B80004240000057 ()
  • B80004240000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU CALIBRATOR LEVEL 4 - B80004240000040

No Description
UTAK LABORATORIES, INC.
DAU CAL 4 V4 F SEMCE
In Commercial Distribution

  • B80004240000040 ()
  • B80004240000041 ()
  • B80004240000042 ()
  • B80004240000043 ()
  • B80004240000046 ()
  • B80004240000047 ()
  • B80004240000048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU CALIBRATOR LEVEL 3 - B80004240000030

No Description
UTAK LABORATORIES, INC.
DAU CAL 3 V4 F SEMCE
In Commercial Distribution

  • B80004240000030 ()
  • B80004240000031 ()
  • B80004240000032 ()
  • B80004240000033 ()
  • B80004240000036 ()
  • B80004240000037 ()
  • B80004240000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
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