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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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OF QC 3 - B80002942500090

No Description
UTAK LABORATORIES, INC.
QC 3 SMX-OF
In Commercial Distribution

  • B80002942500091 ()
  • B80002942500090 ()
  • B80002942500092 ()
  • B80002942500093 ()
  • B80002942500096 ()
  • B80002942500097 ()
  • B80002942500098 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE CALIBRATOR V6 - B80002942500070

No Description
UTAK LABORATORIES, INC.
DOA CAL P OF V6
In Commercial Distribution

  • B80002942500071 ()
  • B80002942500070 ()
  • B80002942500072 ()
  • B80002942500073 ()
  • B80002942500076 ()
  • B80002942500077 ()
  • B80002942500078 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC HIGH - B80002942500060

No Description
UTAK LABORATORIES, INC.
P/Z QC H U F ML
In Commercial Distribution

  • B80002942500060 ()
  • B80002942500061 ()
  • B80002942500062 ()
  • B80002942500063 ()
  • B80002942500066 ()
  • B80002942500067 ()
  • B80002942500068 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC LOW - B80002942500050

No Description
UTAK LABORATORIES, INC.
P/Z QC LOW
In Commercial Distribution

  • B80002942500051 ()
  • B80002942500050 ()
  • B80002942500052 ()
  • B80002942500053 ()
  • B80002942500056 ()
  • B80002942500057 ()
  • B80002942500058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z CALIBRATOR V2 - B80002942500040

No Description
UTAK LABORATORIES, INC.
P/Z CAL V2 U F ML
In Commercial Distribution

  • B80002942500041 ()
  • B80002942500040 ()
  • B80002942500042 ()
  • B80002942500043 ()
  • B80002942500046 ()
  • B80002942500047 ()
  • B80002942500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PSYCH URINE V3 CALIBRATOR - B80002942500030

No Description
UTAK LABORATORIES, INC.
PSY UR V3 CAL
In Commercial Distribution

  • B80002942500030 ()
  • B80002942500031 ()
  • B80002942500032 ()
  • B80002942500033 ()
  • B80002942500036 ()
  • B80002942500037 ()
  • B80002942500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z CALIBRATOR - B80002942500020

No Description
UTAK LABORATORIES, INC.
P/Z CAL U F ML
In Commercial Distribution

  • B80002942500020 ()
  • B80002942500021 ()
  • B80002942500022 ()
  • B80002942500023 ()
  • B80002942500026 ()
  • B80002942500027 ()
  • B80002942500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PM PANEL COMBO V9 - B80002942500010

No Description
UTAK LABORATORIES, INC.
PM PAN COM V9
In Commercial Distribution

  • B80002942500010 ()
  • B80002942500011 ()
  • B80002942500012 ()
  • B80002942500013 ()
  • B80002942500016 ()
  • B80002942500017 ()
  • B80002942500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

VITAMIN D PLUS LEVEL 2 - B80002141500030

No Description
UTAK LABORATORIES, INC.
VIT D+ 2 S KPRICH
In Commercial Distribution

  • B80002141500030 ()
  • B80002141500031 ()
  • B80002141500032 ()
  • B80002141500033 ()
  • B80002141500036 ()
  • B80002141500037 ()
  • B80002141500038 ()


  • Multiple form 25-hydroxy Vitamin D IVD, control

VITAMIN D PLUS LOW - B80002141500010

No Description
UTAK LABORATORIES, INC.
VIT D+ L S KPRICH
In Commercial Distribution

  • B80002141500010 ()
  • B80002141500011 ()
  • B80002141500012 ()
  • B80002141500013 ()
  • B80002141500016 ()
  • B80002141500017 ()
  • B80002141500018 ()


  • Multiple form 25-hydroxy Vitamin D IVD, control

DRUGS OF ABUSE LEVEL 3 - B80002041000030

DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DA 3 S IDC
In Commercial Distribution

  • B80002041000031 ()
  • B80002041000030 ()
  • B80002041000032 ()
  • B80002041000033 ()
  • B80002041000036 ()
  • B80002041000037 ()
  • B80002041000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 2 - B80002041000020

DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 S IDC
In Commercial Distribution

  • B80002041000021 ()
  • B80002041000020 ()
  • B80002041000022 ()
  • B80002041000023 ()
  • B80002041000026 ()
  • B80002041000027 ()
  • B80002041000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 1 - B80002041000010

DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA 1 S IDC
In Commercial Distribution

  • B80002041000011 ()
  • B80002041000010 ()
  • B80002041000012 ()
  • B80002041000013 ()
  • B80002041000016 ()
  • B80002041000017 ()
  • B80002041000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

GHB 20 MG/L - B80001978000020

GHB 20 MG/L
UTAK LABORATORIES, INC.
GHB 20 U IN
In Commercial Distribution

  • B80001978000021 ()
  • B80001978000020 ()
  • B80001978000022 ()
  • B80001978000023 ()
  • B80001978000026 ()
  • B80001978000027 ()
  • B80001978000028 ()


  • Gamma-hydroxybutyrate (GHB) IVD, control

BUSULFAN LEVEL 3 - B80001696000090

BUSULFAN LEVEL 3
UTAK LABORATORIES, INC.
BUS 3 P F UK
In Commercial Distribution

  • B80001696000091 ()
  • B80001696000090 ()
  • B80001696000092 ()
  • B80001696000093 ()
  • B80001696000096 ()
  • B80001696000097 ()
  • B80001696000098 ()


  • Busulfan therapeutic drug monitoring IVD, control

BUSULFAN LEVEL 2 - B80001696000080

BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 P F UK
In Commercial Distribution

  • B80001696000081 ()
  • B80001696000080 ()
  • B80001696000082 ()
  • B80001696000083 ()
  • B80001696000086 ()
  • B80001696000087 ()
  • B80001696000088 ()


  • Busulfan therapeutic drug monitoring IVD, control

BUSULFAN LEVEL 1 - B80001696000070

BUSULFAN LEVEL 1
UTAK LABORATORIES, INC.
BUS 1 P F UK
In Commercial Distribution

  • B80001696000071 ()
  • B80001696000070 ()
  • B80001696000072 ()
  • B80001696000073 ()
  • B80001696000076 ()
  • B80001696000077 ()
  • B80001696000078 ()


  • Busulfan therapeutic drug monitoring IVD, control

METALS LEVEL 2 - B80001696000040

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 DP UK
In Commercial Distribution

  • B80001696000041 ()
  • B80001696000040 ()
  • B80001696000042 ()
  • B80001696000043 ()
  • B80001696000046 ()
  • B80001696000047 ()
  • B80001696000048 ()


  • Multiple heavy metal IVD, control

METALS LEVEL 1 - B80001696000030

METALS LEVEL 1
UTAK LABORATORIES, INC.
MET T 1 DP UK
In Commercial Distribution

  • B80001696000031 ()
  • B80001696000030 ()
  • B80001696000032 ()
  • B80001696000033 ()
  • B80001696000036 ()
  • B80001696000037 ()
  • B80001696000038 ()


  • Multiple heavy metal IVD, control

METALS LEVEL 2 - B80001696000020

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 WB UK
In Commercial Distribution

  • B80001696000021 ()
  • B80001696000020 ()
  • B80001696000022 ()
  • B80001696000023 ()
  • B80001696000026 ()
  • B80001696000027 ()
  • B80001696000028 ()


  • Multiple heavy metal IVD, control

METALS LEVEL 1 - B80001696000010

METALS LEVEL 1
UTAK LABORATORIES, INC.
MET T 1 WB UK
In Commercial Distribution

  • B80001696000011 ()
  • B80001696000010 ()
  • B80001696000012 ()
  • B80001696000013 ()
  • B80001696000016 ()
  • B80001696000017 ()
  • B80001696000018 ()


  • Multiple heavy metal IVD, control

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
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