SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)

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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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Acuitas - 00812125010044

Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gene Panel assay. A 2 mL screwcap tube containing approximately 90,000 CFU of Bacillus subtilis (ATCC 31028) dried down from a solution.
Opgen, Inc.
CP3233
Not in Commercial Distribution

  • 00812125010044 ()
CP3233

  • PCR/NAT negative control IVD

Nubway - 06971679500624

The semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc.
Beijing Nubway S&T Co., Ltd.
QDTM-02
In Commercial Distribution

  • 06971679500624 ()


  • Dermatological diode laser system

Identify Health - 10850013035189

Identify Health 14 Panel CLIA Waived Cup with 6 Adulterations- AMP500, BAR300, BUP10, BZO300, COC150, EDDP300, MDMA500, MET500, MTD300, OPI300, OXY100, PCP25, TCA1000, THC50 - (SG, pH, OX) x (CR, NI, GL) Approx. 3.0mm Strips 25 tests/box
MEDICAL DISTRIBUTION GROUP INC
ID-H14-ADULT-1-AZ25
In Commercial Distribution

  • 00850013035182 ()
  • 10850013035189 ()
ID-H14-ADULT-1-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

not applicable - 00840682122603

No Description
GE MEDICAL SYSTEMS
5727669
In Commercial Distribution

  • 00840682122603 ()


  • Stationary mammographic x-ray system, digital

Senographe Pristina - 00840682118460

No Description
GE MEDICAL SYSTEMS
EKB1
In Commercial Distribution

  • 00840682118460 ()


  • Stationary mammographic x-ray system, digital

Rapid Response - 00722066000847

Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit are for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1P29-25
In Commercial Distribution

  • 00722066000847 ()
  • 00722066004029 ()
D10.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Welch Allyn, Inc. - 00732094067699

Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), Pneumatic Otoscope (#20200), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm)
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094067699 ()
76797-X

  • Basic power supply, reusable

Welch Allyn, Inc. - 00732094066524

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066524 ()
77792-MNOBP

  • Aneroid manual sphygmomanometer

Warrior Lite Blood and Fluid Warmer Base Unit - 07290016740103

QinFlow Warrior Lite Blood and Fluid Warmer Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a LED panel display for user notifications.
QUALITY IN FLOW LTD
QIF-03
In Commercial Distribution

  • 07290016740103 ()
QIF03-BUA1000

  • Conduction blood/fluid warmer

Blue Diamond - 15060797552313

Double Bariatric Pateient Restraint Strap for bariatric patients. Padded mid panel to help protect patient from pressure and sheer injury. Dual extra durable securing straps with airplane style buckles to adjust strap length . Extremely durable and easily cleaned
David Scott Company
BD8000
In Commercial Distribution

  • 15060797552313 ()

  • Width: 12 Inch
  • Length: 80 Inch
BD8000

  • Medical table restraint anchor

Status Toxi Cup - 00868348000256

Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, TCA 1000, THC 50 + pH/CRE/NBP/SG
Lifesign L.L.C.
65C13+4
In Commercial Distribution

  • 10868348000253 ()
  • 00868348000256 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical

Planmeca Compact - 06430035420575

Planmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change.
Planmeca Oy
i5
In Commercial Distribution

  • 06430035420575 ()
30013450, 30015629, 30015630, 30015632, 30015633

  • Dental delivery system

Automatic Radiographic Film Processor - 08809413810181

New retractable feed tray provides space savings for small dark rooms. Exceptionally quiet operation. 1. Microprocessor controlled. 2. High-quality film image 3. The control panel digitally displays. 4. Water level sensor prevents overflowing of tank. 5. Stand-by mode for energy saving.
JPI HEALTHCARE. CO., LTD.
JP-33
In Commercial Distribution

  • 08809413810181 ()


  • Darkroom automated x-ray film processor

STEPHANIX - 03664049000017

D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections. Not for mammography.
STEPHANIX
D2RS
In Commercial Distribution

  • 03664049000017 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

STEPHANIX - 03664049000024

The D2RS_AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. Not for mammography
STEPHANIX
D2RS_AT
In Commercial Distribution

  • 03664049000024 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

ComPel MLR Surgical Gown - 00634916709674

ComPel MLR Surgical Gown, 2-Ply Front, Circumferentially Offset Sleeves, Aqua Compel MLR Outer Sleeves and White Compel MLR with Negastat Inner Sleeves, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Barcode, Overcast Safety Stitch Body Size Large
STANDARD TEXTILE CO., INC.
75674395
In Commercial Distribution

  • 00634916709674 ()
  • 10634916709671 ()
75674395

  • Surgical gown, reusable

Rapid Response - 00722066003541

Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturate, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1P29-25
In Commercial Distribution

  • 00722066003541 ()
  • 00722066004067 ()
D12.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Welch Allyn, Inc. - 00732094136692

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (# 11720), Pneumatic Otoscope (#20201), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094136692 ()
77798

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094121278

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121278 ()
77782-1MP

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094121230

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), Pneumatic Otoscope (#20201), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121230 ()
77797-2PX

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094066876

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066876 ()
77791-2MPX

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094067118

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094067118 ()
77782-M

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094066722

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066722 ()
77792-1MP

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094066548

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066548 ()
77792-M

  • Aneroid manual sphygmomanometer

xTAG® CYP2D6 Kit v3 - 00840487101025

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.
Luminex Molecular Diagnostics, Inc
I030E0443
Not in Commercial Distribution

  • 00840487101025 ()
I030E0443

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

xTAG® CYP2D6 Kit v3 - 00840487100134

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.
Luminex Molecular Diagnostics, Inc
I030B0373
Not in Commercial Distribution

  • 00840487100134 ()
I030B0373

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

Panther Fusion® - 15420045509221

Panther Fusion® Internal Control-S.
Hologic, Inc.
KIT, INTERNAL CONTROL -S, FUSION, IVD
In Commercial Distribution

  • 15420045509221 ()
PRD-04332

  • Exogenous DNA/RNA internal control IVD, kit

NATtrol™ - 01220000260245

NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
ZEPTOMETRIX CORPORATION
NATtrol™ BV Negative Control
Not in Commercial Distribution

  • 01220000260245 ()
NATBVNEG-BD

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control

DEKA HELIX - 08057017760665

The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. • Two wavelengths – CO2 and 1570 nm • Articulated arm • Footswitch • Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator)
EL.EN. SPA
M133A1
In Commercial Distribution

  • 08057017760665 ()
M133A1

  • General/multiple surgical diode/carbon dioxide laser system

Visual Chart System - 08800074500305

CSPOLA600F is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600F can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600F is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600F
In Commercial Distribution

  • 08800074500305 ()
CSPOLA600F

  • Visual acuity light box

Visual Chart System - 08800074500299

CSPOLA600C is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600C can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600C is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600C
In Commercial Distribution

  • 08800074500299 ()
CSPOLA600C

  • Visual acuity light box

Visual Chart System - 08800074500282

CS550 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CS550 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CS550 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CS550
In Commercial Distribution

  • 08800074500282 ()
CS550

  • Visual acuity light box

LCD ACUITY DEVICE - 08800074500152

PROVUE is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for PROVUE can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, PROVUE is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
PROVUE
In Commercial Distribution

  • 08800074500152 ()
PROVUE

  • Visual acuity light box

Visual Chart System - 08800074500114

CSPOLA600 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600
In Commercial Distribution

  • 08800074500114 ()
CSPOLA600

  • Visual acuity light box

Visual Chart System - 08800074500039

VLC-2400P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400P
In Commercial Distribution

  • 08800074500039 ()
VLC-2400P

  • Visual acuity light box

Visual Chart System - 08800074500022

VLC-2400 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400
In Commercial Distribution

  • 08800074500022 ()
VLC-2400

  • Visual acuity light box

Visual Chart System - 08800074500015

VLC-1900P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900P
In Commercial Distribution

  • 08800074500015 ()
VLC-1900P

  • Visual acuity light box

Visual Chart System - 08800074500008

VLC-1900 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900
In Commercial Distribution

  • 08800074500008 ()
VLC-1900

  • Visual acuity light box

Welch Allyn, Inc. - 00732094066784

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), SureColor LED Lamp Technology, KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm)
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066784 ()
77791-MXLED

  • Patient monitoring system module, electrocardiographic

Welch Allyn, Inc. - 00732094067811

Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), Pneumatic Otoscope (#20200), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in /86.4 x 30.5
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094067811 ()
76797-2PX

  • Blood pressure cuff, reusable
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