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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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POWER TILTS - 00606509900102

A set of devices/components that are combined together designed to be used by a person with a disability that allows lifting and tilting movements of objects that they choose to position to keep them accessible.
Pride Mobility Products Corp
POWER TILTS
In Commercial Distribution

  • 00606509900102 ()
N/A

  • Assistive lifting/tilting positioning system

SYMMETRISEAT 50 - 05050962449138

SYMMETRISEAT 50
THE HELPING HAND COMPANY (LEDBURY) LIMITED
FULL POWER
In Commercial Distribution

  • 05050962449138 ()
SKMA1100

  • General examination/treatment chair, electric

Revolution - 00195278518866

Revolution CT Power - Designated System Medical Device
GE MEDICAL SYSTEMS, INC.
CT Power
In Commercial Distribution

  • 00195278518866 ()
5590000-22

  • Full-body CT system

D-LUX+ - 08806383568838

D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
DiaDent Group International
Power Cord
In Commercial Distribution

  • 08806383568838 ()
4008-1161

  • Dental/surgical polymerization lamp

Castellini - 08033837932796

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.
CEFLA SOCIETA' COOPERATIVA
handy POWER
In Commercial Distribution

  • 08033837932796 ()
95520666

  • Dental surgical power tool motor, electric

ESSENZ - 04033817903055

No Description
LivaNova Deutschland GmbH
Power Pack
In Commercial Distribution

  • 04033817903055 ()


  • Cardiopulmonary bypass system, roller type

RCI Optics - G35881103H780

MIDNIGHT GUN COPPER SUNRISE GOLD MIRROR H780
RCI Optics
POWER PLANT
In Commercial Distribution

  • G35881103H780 ()
81103H780

  • Tinted non-prescription spectacles

RCI Optics - G35881102H780

MIDNIGHT GUN GREY ATLANTIC BLUE MIRROR H780
RCI Optics
POWER PLANT
In Commercial Distribution

  • G35881102H780 ()
81102H780

  • Tinted non-prescription spectacles

RCI Optics - G35881005L25

MATTE BLACK BRONZE COPPER FLASH MIRROR L25
RCI Optics
POWER PLANT
In Commercial Distribution

  • G35881005L25 ()
81005L25

  • Tinted non-prescription spectacles

RCI Optics - G35881003H780

MATTE BLACK COPPER SUNRISE GOLD MIRROR H780
RCI Optics
POWER PLANT
In Commercial Distribution

  • G35881003H780 ()
81003H780

  • Tinted non-prescription spectacles

RCI Optics - G35881002H780

MATTE BLACK GREY ATLANTIC BLUE MIRROR H780
RCI Optics
POWER PLANT
In Commercial Distribution

  • G35881002H780 ()
81002H780

  • Tinted non-prescription spectacles

WVSM Wireless Vital Signs Monitor - B3945300025010

AC/DC Power Supply
ATHENA GTX, INC.
Power Adapter
In Commercial Distribution

  • B3945300025010 ()
530-0025-01

  • Basic power supply, reusable

WVSM Wireless Vital Signs Monitor - B3944670019020

A/C Power Cord
ATHENA GTX, INC.
Power Cord
In Commercial Distribution

  • B3944670019020 ()
467-0019-02

  • Electrical mains power cable

WVSM Wireless Vital Signs Monitor - B3944670006010

A/C Power Cord
ATHENA GTX, INC.
Power Cord
In Commercial Distribution

  • B3944670006010 ()
467-0006-01

  • Electrical mains power cable

WVSM Wireless Vital Signs Monitor - B3944670019010

WVSM Power Cord (US)
ATHENA GTX, INC.
Power Cord
In Commercial Distribution

  • B3944670019010 ()
467-0019-01

  • Electrical mains power cable

Insighters - 06970831726186

No Description
Shenzhen Insighters Medical Technology Co., Ltd.
Power Adapter
In Commercial Distribution

  • 06970831726186 ()
868.554

  • Video intubation laryngoscope handle/monitor

Insighters - 06970831726063

No Description
Shenzhen Insighters Medical Technology Co., Ltd.
Power Adapter
In Commercial Distribution

  • 06970831726063 ()


  • Endoscopic video image display unit

BT37 Incubator - B199GDBT37WWORIGIO0

BT37 Benchtop Incubator
PLANER LIMITED
GDBT37-WW-ORIGIO
In Commercial Distribution

  • B199GDBT37WWORIGIO0 ()


  • Assisted reproduction heater/incubator

BT37 Incubator - B199GDBT37USORIGIO0

BT37 Benchtop Incubator.
PLANER LIMITED
GDBT37-US-ORIGIO
In Commercial Distribution

  • B199GDBT37USORIGIO0 ()


  • Assisted reproduction heater/incubator

BT37 Incubator - B199GDBT3701ORIGIO0

BT37 Benchtop Incubator - Origio
PLANER LIMITED
GDBT37-01-ORIGIO
In Commercial Distribution

  • B199GDBT3701ORIGIO0 ()


  • Assisted reproduction heater/incubator

Power Dental USA - D94341260

Power Curettes Serrated Kit..POWER CURETTES SET SERRATED TIPS (5PCS)
Power Dental U.S.A. Inc.
4126
In Commercial Distribution

  • D94341260 ()
4126

  • Dental elevator, tooth/root
  • Periosteal elevator, reusable

Clinton Industries - 00810045931746

Multi-Use, Ultrasound Table with Power Backrest, Power Footrest, and Stirrups
CLINTON INDUSTRIES, INC.
80069-011-090
In Commercial Distribution

  • 00810045931746 ()
80069

  • Examination/treatment table, line-powered

Clinton Industries - 00810045931302

Multi-Use, Ultrasound Table with Power Headrest, Power Footrest, and Stirrups
CLINTON INDUSTRIES, INC.
80069-X-011-090
In Commercial Distribution

  • 00810045931302 ()
80069-X

  • Examination/treatment table, line-powered

Drive - 00822383012117

Power Folding Power Product Description CirrusPlusPowerChair,20 FlpBkArm,1/ea
Drive Devilbiss Healthcare
CP20N
Not in Commercial Distribution

  • 00822383012117 ()


  • Electric-motor-driven wheelchair, occupant-controlled

Drive - 00822383007533

Power Folding Power Product Description CirrusPlusPowerChair,18 FlpBkArm,1/ea
Drive Devilbiss Healthcare
CP18N
In Commercial Distribution

  • 00822383007533 ()


  • Electric-motor-driven wheelchair, occupant-controlled

Drive - 00822383007526

Power Folding Power Product Description CirrusPlusPowerChair,18 FlpBkArm,1/cs
Drive Devilbiss Healthcare
CP18FBAN
Not in Commercial Distribution

  • 00822383007526 ()


  • Electric-motor-driven wheelchair, occupant-controlled

Karman Healthcare - 00810058400024

XO-505 18" Multi Power Function, Power Standing Wheelchair with Tray
KARMAN HEALTHCARE INC.
XO-505-TB
In Commercial Distribution

  • 00810058400024 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

SuperStand Standing Wheelchair - B289PS2

Full-power, power to drive and power to stand, standing wheelchair
STANDING COMPANY, THE
PS-2
In Commercial Distribution

  • B289PS2 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, manual-steering, non-collapsible

Megadyne - 10614559102893

Mega Power Top Shelf for use with Mega Power Cart
MEGADYNE MEDICAL PRODUCTS, INC.
1350
Not in Commercial Distribution

  • 10614559102893 ()


  • Electrosurgical system generator

FIZE kUO Console - 07290019239031

FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US catalog number: FKUO5.0G_PB_US FIZE kUO console 5G with power supply US catalog number: FKUO5.0G_PS_US
FIZE RESEARCH LTD
5G2
In Commercial Distribution

  • 17290019239038 ()
  • 07290019239031 ()
  • 27290019239035 ()
FI-FG00-KU00-0006

  • Urine monitoring system

FIZE kUO Console - 07290019239024

FIZE kUO Console 2.4G catalog number: FI-FG00-KU00-0005 FIZE kUO Console 2.4G with power box US catalog number: FKUO2.4G_PB_US FIZE kUO Console 2.4G with power supply US catalog number: FKUO2.4G_PS_US
FIZE RESEARCH LTD
2.4G2
In Commercial Distribution

  • 17290019239021 ()
  • 07290019239024 ()
  • 27290019239028 ()
FI-FG00-KU00-0005

  • Urine monitoring system

MSI Precision Specialty Instruments - 00194613087241

Nichamin Degreega / Fixation Ring, Titanium, Open Front 10 Degrees Markings, Broad Hash Marks, 180 Degrees Apart, Fixation Teeth, 12mm Inner Diameter, Round Knurled Handle, Overall Length 112mm
Med Saver, Inc.
5-3534-T
In Commercial Distribution

  • 00194613087241 ()


  • Eyeball fixation instrument, reusable

MOVE 78 Cold & Flu Kit - 00850031915053

MOVE 78 Cold & Flu Kit comprises of a Touchless Infrared thermometer and a pulse oximeter. Both devices are bluetooth enabled.
TREND POWER LIMITED
MOVE78-ESS
In Commercial Distribution

  • 10850031915050 ()
  • 00850031915053 ()


  • Pulse oximeter
  • Infrared patient thermometer, skin

BIOSITE/BIOSITE PLUS - B134JR044AU2

JR-044-AU BiositeTransfer Spike
MACLIN POWER, INC.
JR-044-AU
In Commercial Distribution

  • B134JR044AU2 ()
  • B134JR044AU0 ()
JR-044-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR025BU2

JR-025-BU Biosite with Flow Control
MACLIN POWER, INC.
JR-025-BU
In Commercial Distribution

  • B134JR025BU2 ()
  • B134JR025BU0 ()
JR-025-BU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR025AU2

JR-025-AU Biosite with Flow Control
MACLIN POWER, INC.
JR-025-AU
In Commercial Distribution

  • B134JR025AU2 ()
  • B134JR025AU0 ()
JR-025-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR024AU2

JR-024-AU Biosite Adult Bifurcated Extension Tube
MACLIN POWER, INC.
JR-024-AU
In Commercial Distribution

  • B134JR024AU2 ()
  • B134JR024AU0 ()
JR-024-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR021SU2

JR-021-SU Biosite Neonatal Bifurcated Extension Tube - Luer Slip
MACLIN POWER, INC.
JR-021-SU
In Commercial Distribution

  • B134JR021SU2 ()
  • B134JR021SU0 ()
JR-021-SU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR021LU2

JR-021-LU Biosite Neonatal Bifurcated Extension Tube - Luer Lock
MACLIN POWER, INC.
JR-021-LU
In Commercial Distribution

  • B134JR021LU2 ()
  • B134JR021LU0 ()
JR-021-LU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR020SU2

JR-020-SU Biosite Pedriatric Bifurcated Extension Tube - Luer Slip
MACLIN POWER, INC.
JR-020-SU
In Commercial Distribution

  • B134JR020SU2 ()
  • B134JR020SU0 ()
JR-020-SU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR020LU2

JR-020-LU Biosite Pediatric Bifurcated Extension Tube - Luer Lock
MACLIN POWER, INC.
JR-020-LU
In Commercial Distribution

  • B134JR020LU2 ()
  • B134JR020LU0 ()
JR-020-LU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR019AU2

JR-019-AU Biosite Extension with Nutrition Filter
MACLIN POWER, INC.
JR-019-AU
In Commercial Distribution

  • B134JR019AU2 ()
  • B134JR019AU0 ()
JR-019-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR018SU2

JR-018-SU Biosite Neonatal Extension Tube - Luer Slip
MACLIN POWER, INC.
JR-018-SU
In Commercial Distribution

  • B134JR018SU2 ()
  • B134JR018SU0 ()
JR-018-SU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR018LU2

JR-018-LU Biosite Neonatal Extension Tube - Luer Lock
MACLIN POWER, INC.
JR-018-LU
In Commercial Distribution

  • B134JR018LU2 ()
  • B134JR018LU0 ()
JR-018-LU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR017AU2

JR-017-AU Biosite Extension with Solution Filter
MACLIN POWER, INC.
JR-017-AU
In Commercial Distribution

  • B134JR017AU2 ()
  • B134JR017AU0 ()
JR-017-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR016AU2

JR-016-AU Biosite Pedriatric Extension Tube
MACLIN POWER, INC.
JR-016-AU
In Commercial Distribution

  • B134JR016AU2 ()
  • B134JR016AU0 ()
JR-016-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR015AU2

JR-015-AU Biosite Surgical Set with Check Valve
MACLIN POWER, INC.
JR-015-AU
In Commercial Distribution

  • B134JR015AU2 ()
  • B134JR015AU0 ()
JR-015-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR014AU2

JR-014-AU Bioste Adult Extension Tube
MACLIN POWER, INC.
JR-014-AU
In Commercial Distribution

  • B134JR014AU2 ()
  • B134JR014AU0 ()
JR-014-AU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR012CU2

JR-012-CU Biosite Volumetric Set - 150 Ml
MACLIN POWER, INC.
JR-012-CU
In Commercial Distribution

  • B134JR012CU2 ()
  • B134JR012CU0 ()
JR-012-CU

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134JR012AU2

JR-012-AU Biosite Volumetric Set - 100 Ml
MACLIN POWER, INC.
JR-012-AU
In Commercial Distribution

  • B134JR012AU2 ()
  • B134JR012AU0 ()
JR-012-AU

  • Intravenous administration tubing extension set
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