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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

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

NEEDLE, AIR ASPIRATOR 16 GA W/BLUE CAP - B066201005NS1

A 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. It is not intended for administration of pharmaceuticals. This is a single-use device.
NOVOSCI CORP.
201005NS
In Commercial Distribution

  • B066201005NS6 ()
  • B066201005NS1 ()
  • B066201005NS5 ()
  • B066201005NS4 ()
  • B066201005NS3 ()
  • B066201005NS2 ()
  • B066201005NS0 ()
201005NS

  • Body aspiration needle, single-use
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