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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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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

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

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

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

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 - 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. - 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. - 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. - 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

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

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

Illumeo - 00884838093997

illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.2
In Commercial Distribution

  • 00884838093997 ()
45980163324X

  • Radiology picture archiving and communication system workstation
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