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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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URINE QC HIGH - B80001390500040

No Description
UTAK LABORATORIES, INC.
U QC HIGH V2 EL
In Commercial Distribution

  • B80001390500040 ()
  • B80001390500041 ()
  • B80001390500042 ()
  • B80001390500043 ()
  • B80001390500046 ()
  • B80001390500047 ()
  • B80001390500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

URINE QC LOW - B80001390500030

No Description
UTAK LABORATORIES, INC.
U QC LOW V2 EL
In Commercial Distribution

  • B80001390500030 ()
  • B80001390500031 ()
  • B80001390500032 ()
  • B80001390500033 ()
  • B80001390500036 ()
  • B80001390500037 ()
  • B80001390500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

URINE QC HIGH - B80001390500020

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

  • B80001390500021 ()
  • B80001390500020 ()
  • B80001390500022 ()
  • B80001390500023 ()
  • B80001390500026 ()
  • B80001390500027 ()
  • B80001390500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

URINE QC LOW - B80001390500010

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 - B80000357500030

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 - B80000357500020

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

StaClear - B994SC250LS0

The StaClear Model SC250LS Syringe is a single-use piston syringe consisting of a graduated barrel with luer slip connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LS Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250LS
In Commercial Distribution

  • B994SC250LS2 ()
  • B994SC250LS0 ()
  • B994SC250LS5 ()
  • B994SC250LS7 ()
  • B994SC250LS3 ()
  • B994SC250LS6 ()
  • B994SC250LS8 ()

  • Total Volume: 0.25 Milliliter


  • General-purpose syringe/needle

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

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

Movement and Compressions System (MAC) - B547RF14300

MAC Charger
Recovery Force, LLC
B
In Commercial Distribution

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

  • Length: 203 Millimeter
RF1430

  • Intermittent venous compression system
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