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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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QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM4ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM4ASH0 ()
  • QCTPROM4ASHN0100 ()
  • QCTPROM4ASHN0075 ()
  • QCTPROM4ASHN0050 ()
  • QCTPROM4ASHN0025 ()
  • QCTPROM4ASHN0010 ()
  • QCTPROM4ASHN0005 ()
  • QCTPROM4ASHN0003 ()
  • QCTPROM4ASHN0002 ()
  • QCTPROM4ASHN0500 ()
  • QCTPROM4ASHN0200 ()
QCTPROM4ASH

  • CT system application software

RED - B960RED201

The Rectal Expulsion Device (RED) is a catheter with a proprietary open-cell foam balloon that naturally expands when inserted into the rectum. RED is used to evaluate the neuromuscular function of the patient's ability to expel its content from the rectum and a qualitative test for rectal hypersensitivity. It is intended to be used in a clinical setting by providers in adult populations. RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume the foam displaces when inflated with room air is 52 - 60 ml. This passive expansion provides the same function as filling an empty balloon with water or air, but the proprietary foam behaves and feels like normal stool. When expanded, the volume of material inside the patient’s rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate at lower volumes. This is measured by asking patients a few questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually. Cartons may have 1-5 devices as needed.
Neuraxis, Inc.
02 2050 RED
In Commercial Distribution

  • B960RED201 ()
  • B960RED2011 ()
  • B960RED2012 ()
  • REDDEVICES5 ()
  • B960RED2010 ()
  • B960RED2016 ()
  • B960RED2015 ()
  • B960RED2013 ()
  • B960RED2014 ()
  • B960RED2017 ()
  • B960RED2018 ()
02-2050

  • Rectosphincteric balloon
  • Gastrointestinal motility manometric catheter, non-electronic

Spetzler - OMT - M731100020

Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
OMT, LLC
Neuro Patties
In Commercial Distribution

  • M731100020 ()
  • K900010 ()
  • M7311100149 ()
  • M7311100139 ()
  • M7311100129 ()
  • M7311100119 ()
  • M7311100109 ()
  • M7311100179 ()
  • M731110199 ()
  • M7311100199 ()
ALL

  • Cottonoid pad

StaClear - B994SC250LL0

The StaClear Model SC250LL Syringe is a single-use piston syringe consisting of a graduated barrel with luer lock connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LL Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250LL
In Commercial Distribution

  • B994SC250LL0 ()
  • B994SC250LL1 ()
  • B994SC250LL5 ()
  • B994SC250LL2 ()
  • B994SC250LL3 ()
  • B994SC250LL4 ()
  • B994SC250LL6 ()
  • B994SC250LL7 ()

  • Total Volume: 0.25 Milliliter
SC250LL

  • General-purpose syringe/needle

VLGR LEVEL 3 - B80002509000070

No Description
UTAK LABORATORIES, INC.
VLGR 3 S F MAYO
In Commercial Distribution

  • B80002509000070 ()
  • B80002509000071 ()
  • B80002509000072 ()
  • B80002509000073 ()
  • B80002509000076 ()
  • B80002509000077 ()
  • B80002509000078 ()
  • B80002509000079 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

VLGR LEVEL 2 - B80002509000060

No Description
UTAK LABORATORIES, INC.
VLGR 2 S F MAYO
In Commercial Distribution

  • B80002509000060 ()
  • B80002509000061 ()
  • B80002509000062 ()
  • B80002509000063 ()
  • B80002509000066 ()
  • B80002509000067 ()
  • B80002509000068 ()
  • B80002509000069 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

VLGR LEVEL 1 - B80002509000050

No Description
UTAK LABORATORIES, INC.
VLGR 1 S F MAYO
In Commercial Distribution

  • B80002509000050 ()
  • B80002509000051 ()
  • B80002509000052 ()
  • B80002509000053 ()
  • B80002509000056 ()
  • B80002509000057 ()
  • B80002509000058 ()
  • B80002509000059 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

NORMAL HUMAN SERUM - B80002509000040

No Description
UTAK LABORATORIES, INC.
44600-S(MAYO)
In Commercial Distribution

  • B80002509000040 ()
  • B80002509000041 ()
  • B80002509000042 ()
  • B80002509000043 ()
  • B80002509000046 ()
  • B80002509000047 ()
  • B80002509000048 ()
  • B80002509000049 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PURE ENRICHMENT - B311PEPROPAD0

PACK OF ELECTRODES
BEAR DOWN CONSULTING
PEPROPAD
In Commercial Distribution

  • B311PEPROPAD0 ()
  • B311PEPROPAD4 ()
  • B311PEPROPAD3 ()
  • B311PEPROPAD2 ()
  • B311PEPROPAD1 ()
  • B311PEPROPAD5 ()
  • B311PEPROPAD6 ()


  • Transcutaneous electrical stimulation electrode, single-use

URINE BROAD PANEL HIGH - B30001346000010

No Description
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B30001346000010 ()
  • B30001346000011 ()
  • B30001346000012 ()
  • B30001346000013 ()
  • B30001346000016 ()
  • B30001346000017 ()
  • B30001346000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PURE ENRICHMENT - B311PETENSPAD0

ELECTRODE PADS
BEAR DOWN CONSULTING
PETENSPAD
In Commercial Distribution

  • B311PETENSPAD5 ()
  • B311PETENSPAD0 ()
  • B311PETENSPAD4 ()
  • B311PETENSPAD3 ()
  • B311PETENSPAD2 ()
  • B311PETENSPAD1 ()
  • B311PETENSPAD6 ()


  • Transcutaneous electrical stimulation electrode, single-use

CONNECTOR, ADAPTER NEEDLE LUER - B066102357NS1

A non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device.
NOVOSCI CORP.
102357NS
In Commercial Distribution

  • B066102357NS1 ()
  • B066102357NS7 ()
  • B066102357NS6 ()
  • B066102357NS5 ()
  • B066102357NS4 ()
  • B066102357NS3 ()
  • B066102357NS2 ()
  • B066102357NS0 ()
102357NS

  • Non-ISO80369-standardized small-bore linear connector, 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

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

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

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
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